Clinical trial NCT04434937
Conditions: Lymphoma
Keywords: Follicular Lymphoma Parsaclisib PI3Kδ Inhibitor
Sponsor: Incyte Biosciences Japan GK
Start date: 2020-09-30; Completion date: 2023-10-13
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the efficacy and safety of parsaclisib in Japanese participants with relapsed or refractory follicular lymphoma

Detailed description:

Arms: arm 1: parsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits
Interventions: intervention 1: parsaclisib
Intervention descriptions: intervention 1: parsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits

Protocol documents:
Prot_000.pdf: 
Official Title:    A Phase 2, Multicenter, Open-Label Study of Parsaclisib, a PI3Kδ Inhibitor, 
in Japanese Participants With Relapsed or Refractory Follicular Lymphoma 
(CITADEL-213) 
NCT Number: 
 NCT04434937 
Document Date:     Clinical Study Protocol (Amendment 4.0): 24-January-2023


Incyte Biosciences Japan GK 
Page 1 of 90 
Protocol INCB 50465-213 Am 4 
Version 5 
24 JAN 2023 
VV-CLIN-011208
CONFIDENTIAL 
TITLE PAGE 
Clinical Study Protocol 
INCB 50465-213 
A Phase 2, Multicenter, Open-Label Study of Parsaclisib, a PI3Kδ 
Inhibitor, in Japanese Participants With Relapsed or Refractory 
Follicular Lymphoma 
(CITADEL-213) 
Product: 
INCB050465 
Phase of Study: 
2 
Sponsor: 
Incyte Biosciences Japan GK 
1-1-2 Yurakucho Chiyoda-ku
Tokyo 100-0006, Japan
Original Protocol: 
07 APR 2020 
Amendment 1 (Version 2): 
25 JUN 2020 
Amendment 2 (Version 3): 
19 MAY 2021 
Amendment 3 (Version 4): 
07 OCT 2022 
Amendment 4 (Version 5): 
24 JAN 2023 
This study will be performed in accordance with ethical principles that have their origin in the Declaration of 
Helsinki (Brazil 2013) and conducted in adherence to the study Protocol, applicable Good Clinical Practices, and 
applicable laws and country-specific regulations, including WMO (Medical Research Involving Human Participants 
Act) and Clinical Trials Regulation (EU) No. 536/2014, in which the study is being conducted. 
The information in this document is confidential. No part of this information may be duplicated, referenced, or 
transmitted in any form or by any means (electronic, mechanical, photocopy, recording, or otherwise) without prior 
written consent. 


Incyte Biosciences Japan GK 
Page 2 of 90 
Protocol INCB 50465-213 Am 4 
Version 5 
24 JAN 2023 
VV-CLIN-011208 
CONFIDENTIAL 
INVESTIGATOR'S AGREEMENT 
I have read the INCB 50465-213 Protocol Amendment 4 (dated 24 JAN 2023) and agree to 
conduct the study as outlined.  I agree to maintain the confidentiality of all information received 
or developed in connection with this Protocol. 
 
 
 
 
 
(Printed Name of Investigator) 
 
 
 
 
 
 
 
 
(Signature of Investigator) 
 
(Date) 


Incyte Biosciences Japan GK 
Page 3 of 90 
Protocol INCB 50465-213 Am 4 
Version 5 
24 JAN 2023 
VV-CLIN-011208 
CONFIDENTIAL 
TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
INVESTIGATOR'S AGREEMENT ................................................................................................2 
TABLE OF CONTENTS .................................................................................................................3 
LIST OF ABBREVIATIONS ..........................................................................................................8 
1. 
PROTOCOL SUMMARY ..........................................................................................11 
2. 
INTRODUCTION ......................................................................................................19 
2.1. 
Background .................................................................................................................19 
2.1.1. 
Follicular Lymphoma .................................................................................................19 
2.1.2. 
Treatment of Follicular Lymphoma ............................................................................20 
2.1.3. 
Parsaclisib ...................................................................................................................20 
2.2. 
Study Rationale ...........................................................................................................21 
2.2.1. 
Scientific Rationale for Study Design ........................................................................21 
2.2.2. 
Justification for Dose ..................................................................................................21 
2.3. 
Benefit/Risk Assessment ............................................................................................22 
3. 
OBJECTIVES AND ENDPOINTS ............................................................................23 
4. 
STUDY DESIGN .......................................................................................................24 
4.1. 
Overall Design ............................................................................................................24 
4.2. 
Overall Study Duration ...............................................................................................25 
4.3. 
Study Termination ......................................................................................................25 
5. 
STUDY POPULATION .............................................................................................26 
5.1. 
Inclusion Criteria ........................................................................................................26 
5.2. 
Exclusion Criteria .......................................................................................................27 
5.3. 
Lifestyle Considerations .............................................................................................29 
5.4. 
Screen Failures ............................................................................................................29 
5.5. 
Replacement of Participants .......................................................................................29 
5.6. 
Data Monitoring Committee .......................................................................................29 
6. 
STUDY TREATMENT ..............................................................................................30 
6.1. 
Study Treatment Administered ...................................................................................30 
6.2. 
Preparation, Handling, and Accountability ................................................................30 
6.2.1. 
Supply, Packaging, and Labeling ...............................................................................30 
6.2.2. 
Storage ........................................................................................................................30 


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Incyte Biosciences Japan GK 
Page 11 of 90 
Protocol INCB 50465-213 Am 4 
Version 5 
24 JAN 2023 
VV-CLIN-011208 
CONFIDENTIAL 
1. 
PROTOCOL SUMMARY 
Protocol Title:  A Phase 2, Multicenter, Open-Label Study of Parsaclisib, a PI3Kδ Inhibitor, in 
Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213) 
Protocol Number:  INCB 50465-213 
Objectives and Endpoints: 
Table 1 presents the primary and key secondary endpoints and objectives. 
Table 1: 
Primary and Secondary Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To assess the efficacy of parsaclisib in terms of 
ORR in participants with relapsed or refractory 
FL. 
ORR, defined as the percentage of participants 
with a CR or PR as defined by revised response 
criteria for lymphomas (Cheson et al 2014), as 
determined by an IRC. 
Key Secondary 
To assess CRR. 
CRR, defined as the percentage of participants 
with a CR as defined by revised response criteria 
for lymphomas (Cheson et al 2014), as 
determined by an IRC. 
To assess DOR. 
DOR, defined as the time from first documented 
evidence of CR or PR until disease progression or 
death from any cause among participants who 
achieve an objective response, as determined by 
radiographic disease assessment provided by an 
IRC. 
To assess PFS. 
PFS, defined as the time from the date of the first 
dose of study treatment until the earliest date of 
disease progression, as determined by 
radiographic disease assessment provided by an 
IRC, or death from any cause. 
To assess OS. 
OS, defined as the time from the date of the first 
dose of study treatment until death from any 
cause. 
To assess best percentage change in target lesion 
size. 
Best percentage change in target lesion size from 
baseline, where target lesion size is measured by 
the sum of the product of the diameters of all 
target lesion sizes. 
To characterize the safety and tolerability of 
parsaclisib. 
Safety and tolerability assessed by monitoring the 
frequency and severity of AEs; includes 
performing physical examinations and collecting 
vital signs, 12-lead ECGs, and clinical laboratory 
data. 


Incyte Biosciences Japan GK 
Page 12 of 90 
Protocol INCB 50465-213 Am 4 
Version 5 
24 JAN 2023 
VV-CLIN-011208 
CONFIDENTIAL 
Overall Design: 
Table 2 presents the key study design elements.  Further study details are presented after the 
table. 
Table 2: 
Key Study Design Elements 
Study Phase 
Phase 2 
Clinical Indication 
Relapsed or refractory FL  
Population 
Male and female Japanese participants at least 18 years of age who have 
relapsed or refractory FL (Grade 1, 2 or 3a) with disease progression after 2 or 
more prior systemic therapies 
Number of 
Participants 
Approximately 40 participants with history of 2 or more lines of treatment will 
be enrolled.  Approximately 18 participants should have history of ASCT. 
Study Design 
Single arm, open-label  
Participants will receive parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg 
QD.  Participants will be evaluated for ORR by an IRC and followed for CRR, 
DOR, PFS, OS, and safety.  Participants may receive treatment until disease 
progression, death, unacceptable toxicity, or consent withdrawal. 
An interim futility analysis is planned when the first 20 participants have been 
evaluated for response or have been followed for at least 9 weeks or have 
permanently discontinued study treatment because of disease progression, 
withdrawal of consent, or death.  Enrollment will continue during the interim 
futility analysis.  The study will be terminated for futility if ≤ 7 of the 
20 participants have responded (ie, CR or PR) based on assessments provided 
by the IRC; otherwise the study will continue.  A timely assessment of 
response will be performed to avoid the risk of overenrollment.  
Estimated Duration 
of Study 
Participation 
Up to 28 days for screening, continuous treatment as long as participants are 
receiving benefit and have not met any criteria for study treatment withdrawal, 
30 to 35 days for safety follow-up, and disease and survival follow-up until the 
end of the study.  It is estimated that an individual will participate for an 
average of approximately 16 months, which includes each period mentioned 
above. 
IDMC 
Yes (external) 
Treatment Groups and Duration: 
This is a Phase 2, multicenter, open-label study evaluating parsaclisib treatment based on the 
primary endpoint of ORR.  The study treatment will be administered orally.  Participants may 
receive treatment until disease progression, death, HSCT (if become eligible) or unacceptable 
toxicity, or consent withdrawal. 
Figure 1 presents the study design schema. 


Incyte Biosciences Japan GK 
Page 13 of 90 
Protocol INCB 50465-213 Am 4 
Version 5 
24 JAN 2023 
VV-CLIN-011208 
CONFIDENTIAL 
Figure 1: 
Study Design Schema 
 
Adherence to the study design requirements, including those specified in the SoA, is essential 
and required for study conduct. 


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Incyte Biosciences Japan GK 
Page 15 of 90 
Protocol INCB 50465-213 Am 4 
Version 5 
24 JAN 2023 
VV-CLIN-011208 
CONFIDENTIAL 
Table 3: 
Schedule of Activities (Continued) 
Procedure 
Screening 
Treatment 
EOT 
Follow-Up 
Notes and Protocol Section 
Safety 
Disease 
Survival 
Day –28 
to –1 
Day 1* 
Every 4 Weeks 
Through Week 48 
(± 3 Days) 
Every 12 Weeks 
From Week 48 
(± 1 Week) 
EOT 
+30-35 
Days 
 
Every 
12 Weeks 
(± 1 Week) 
after EOT 
*All procedures are to be performed 
before administration of study 
treatment. 
CT/MRI scan 
X 
 
Every 8 weeks through Week 24 
(± 1 week), then every 12 weeks 
through Week 96, and then every 
24 weeks thereafter until PD. 
 
 
X* 
 
*Only for participants who discontinue 
study treatment for reasons other than 
disease progression.  Will continue to 
be performed per assessment schedule 
(every 8, 12, 24 weeks as appropriate) 
until disease progression, start of new 
anti-lymphoma therapy, withdrawal of 
consent, end of the study, or death, 
whichever occurs first. 
Section 8.2.1. 
Bone marrow exam 
X 
 
X* 
X* 
 
 
X* 
 
Required at baseline except if 
participant had a bone marrow exam 
per standard of care within ~60 days of 
first dose or had a previous exam after 
the last therapy. 
*If disease is present in bone marrow at 
baseline, a bone marrow biopsy is 
required to confirm CR. 
Section 8.2.2. 
FDG-PET 
X 
 
 
 
 
 
 
 
Only for participants who submit earlier 
archived lymph nodes or tissue biopsies 
instead of newly obtained samples after 
the previous therapy. 
If FDG-PET assessment was performed 
as standard of care before signing of the 
ICF, but within 28 days of Day 1, then 
the results from that assessment can be 
used. 
PJP prophylaxis 
 
X 
PJP prophylaxis will continue for 2 to 
6 months after the last dose of study 
treatment. 
Section 6.6.1. 


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Incyte Biosciences Japan GK 
Page 18 of 90 
Protocol INCB 50465-213 Am 4 
Version 5 
24 JAN 2023 
VV-CLIN-011208 
CONFIDENTIAL 
Table 4: 
Schedule of Laboratory Assessments (Continued) 
Laboratory Tests 
Screening 
Treatment 
EOT 
Safety 
Follow-Up 
Notes and Protocol Section 
Day –28 
to –1 
Day 1 
Week 2 and 
Week 6 
(± 3 Days) 
Every 4 Weeks 
Through Week 48 
(± 3 Days), 
(Week 4 included) 
Every 12 Weeks 
From Week 48 
(± 1 Week) 
EOT + 
30-35 Days 
Tumor biopsy 
X 
 
 
X* 
 
X* 
 
Participants must be willing to undergo an incisional, 
excisional or core needle lymph node or tissue biopsy 
or provide a lymph node or tissue biopsy after 
completion of the last therapy. 
*An optional biopsy at Week 4 and is encouraged.  A 
lymph node or tissue biopsy is strongly encouraged at 
time of progression OR at time of relapse following 
response of PR or better. 
Tumor biopsy is not mandatory for participants who 
submit earlier archived lymph nodes or tissue 
biopsies. 
Section 8.5.3. 


Incyte Biosciences Japan GK 
Page 19 of 90 
Protocol INCB 50465-213 Am 4 
Version 5 
24 JAN 2023 
VV-CLIN-011208 
CONFIDENTIAL 
2. 
INTRODUCTION 
2.1. 
Background 
2.1.1. 
Follicular Lymphoma 
Non-Hodgkin lymphoma is the most common hematologic malignancy, with over 385,000 new 
cases diagnosed in 2012 (Torre et al 2015).  Follicular lymphoma, a subtype of NHL, is the 
second most prevalent form of NHLs overall, accounting for approximately 1 in 5 cases of NHL, 
and is the most common form of indolent (slow-growing) NHLs.  More than 75,000 people are 
estimated to be diagnosed with FL annually worldwide (Shankland et al 2012). 
Follicular lymphoma is defined as a lymphoma of germinal center B cells, including centrocytes 
and centroblasts, that has at least a partially follicular pattern.  These bone marrow–derived cells 
undergo somatic hypermutation and class switching of the B-cell receptors, which leads to 
immunoglobulin diversity and selects B cells that produce high-affinity antibodies (Kahl and 
Yang 2016).  Central to the early transformation and pathophysiology of FL is the 
t(14;18)(q32;18) translocation found in approximately 90% of FL and that leads to 
overexpression of BCL2 (Pastore et al 2015).  Follicular lymphoma is also positive for the B-cell 
markers CD10, CD19, CD22, and usually CD20 but is always negative for CD5 (Barekman et al 
2001). 
The 2008 WHO classification system (Swerdlow et al 2016) divides FL into grades based on the 
proportion of centrocytes to centroblasts.  Cases with more centroblasts tend to be more 
aggressive and are more likely to transform in to diffuse large-cell lymphoma (Kahl and Yang 
2016).  Grade 1 is defined as 0 to 5 centroblasts per HPF, Grade 2 is 6 to 15 centroblasts per 
HPF, and Grade 3 is > 15 centroblasts per HPF.  Grade 3 can be subclassified into 3a and 3b, 
with the latter distinguished by an absence of centrocytes.  FL3b appears to be biologically 
distinct compared with the other grades, with frequent absence of both t(14;18) and CD10 
expression and increased p53 and MUM1/IRF4 expression.  FL3b is commonly treated 
according to the treatment recommendations for DLBCL (NCCN 2020). 
Although FL is a biologically heterogeneous disease with widely varying outcomes, the 
prognosis for individual patients can be made based on clinical and laboratory findings.  The 
most widely used risk model for FL is the FLIPI, which includes 5 adverse prognostic 
factors:  age older than 60 years, Ann Arbor Stage III to IV, hemoglobin less than 120 g/L, 4 or 
more involved nodal areas, and elevated serum lactate dehydrogenase (Solal-Céligny et al 2004; 
Appendix E).  Following treatment, patients can be assessed for MRD, which refers to the small 
number or cancer cells that might remain after treatment and which may lead to relapse. 
While effective treatments exist for FL, relapse is frequent and is followed by aggressive disease 
often leading to death within 1 to 2 years.  Based on an analysis of 588 patients receiving 
R-CHOP as initial FL therapy, approximately 20% of patients experienced early PD, defined as 
PD within 2 years of diagnosis.  The 5-year OS was 50% in the early PD group compared with 
90% in patients without early PD (Casulo et al 2015).  Thus, despite significant progress in the 
management of patients with FL, an unmet need exists. 


Incyte Biosciences Japan GK 
Page 20 of 90 
Protocol INCB 50465-213 Am 4 
Version 5 
24 JAN 2023 
VV-CLIN-011208
CONFIDENTIAL 
2.1.2. 
Treatment of Follicular Lymphoma 
Some patients with early stage FL (Ann Arbor Stage I or II) who develop symptoms may be 
treated with radiation therapy alone.  Advanced stage (Ann Arbor Stage III-IV), Grade 1 to 3a 
FL is often treated according to the degree of tumor burden (low versus high) and the presence or 
absence of FL symptoms (eg, fever, night sweats, unexplained weight loss, etc).  Asymptomatic 
patients with a low tumor burden may be candidates for watchful waiting, whereas those with a 
high tumor burden may receive R-chemo.  Symptomatic patients with a low tumor burden may 
receive either single-agent rituximab or R-chemo, whereas patients with a high tumor burden 
may receive R-chemo with or without maintenance rituximab.  Although the majority of patients 
will respond to these first-line therapies, the natural history of FL is characterized by continuous 
relapse (Izutsu 2019). 
There are several options for patients with FL that relapse after initial treatment (Kahl and Yang 
2016).  Recent new option for relapsed FL is PI3K inhibitors.  The PI3Kδ inhibitor idelalisib was 
approved for the treatment of patients in the United States with relapsed follicular B-cell NHL 
who have received at least 2 prior systemic therapies.  The PI3K inhibitor copanlisib and 
duvelisib were also approved in the Unites States for the same patient population in September 
of 2017 and September of 2018, respectively (Aliqopa® 2020, Copiktra® 2019).  Idelalisib was 
approved in the European Union for the treatment of adult patients with FL that is relapse or 
refractory to 2 prior lines of treatment.  However, idelalisib, copanlisib, and duvelisib are not 
approved in Japan.  The relapsed patient population is currently underserved by the available 
approved therapies in many countries and, like the double-refractory to rituximab (monotherapy or 
in combination) and to either chemotherapy or radioimmunotherapy population, represents an unmet 
medical need.  This is especially true in patients that are ineligible for HSCT and relapse after 
high dose chemotherapy followed by ASCT and allogeneic SCT.  To address the unmet medical 
need of these populations, and to enroll the study in a timely fashion, the study will allow 
participants who have either relapsed or refractory disease after at least 2 prior systemic therapies 
and who are ineligible for HSCT. 
2.1.3. 
Parsaclisib 
Phosphatidylinositol 3-kinases belong to a family of lipid signaling kinases that phosphorylate 
phosphoinositides of the inositol ring (Cantley 2002).  Phosphatidylinositol 3 kinases are divided 
into 3 classes (Class I, II, and III) according to their structure, regulation, and substrate 
specificity.  Class I PI3Ks, which include PI3Kα, PI3Kβ, PI3Kγ, and PI3Kδ, are dual-specificity 
lipid and protein kinases that catalyze the phosphorylation of phosphatidylinositol-4,5-
bisphosphate, giving rise to phosphatidylinositol-3,4,5-trisphosphate.  Phosphatidylinositol-
3,4,5-trisphosphate functions as a second messenger that controls a number of cellular processes, 
including growth, survival, adhesion, and migration.  The recognition that aberrant signal 
transduction occurs in malignant B-lymphocytes via the PI3K pathways resulting in disease 
progression has led to a focus on agents that modulate these signaling pathways. 
Parsaclisib is a potent inhibitor of PI3Kδ (IC50 value = 1.1 ± 0.5 nM), with approximately 
20,000-fold selectivity for the other PI3K family members.  Parsaclisib does not significantly 
inhibit (< 30% inhibition) a broad panel of kinases when tested at a concentration of 100 nM 
(refer to the parsaclisib IB).  Parsaclisib is potent (IC50 values of ≤ 10 nM) in cell-based assays 
relevant to the pathogenesis of B-cell malignancies, such as PI3Kδ-mediated signaling and 


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growth of human B-cell lines.  This effect is not due to general cytotoxicity.  Compared with 
inhibition of B-cell proliferation, parsaclisib is similarly potent in blocking helper T-cell 
differentiation but is > 100 times less potent in assays that measure effects on human T-cell and 
natural killer cell proliferation or monocyte function.  These data suggest that the impact of 
parsaclisib on the human immune system will largely be restricted to B-cell and helper T-cell 
differentiation.  The IC90 for pAKT inhibition of Pfeiffer cells in human whole blood is 77 nM.  
Preclinical toxicology studies supported evaluation of parsaclisib in human clinical studies 
(parsaclisib IB). 
A Phase1/2, dose-escalation and expansion study, INCB 50465-101, demonstrated the vast 
majority (93%) of responses occurred by the first assessment (~9 weeks) in participants with 
relapsed or refractory B-cell lymphoma who received parsaclisib monotherapy.  The most 
common (≥ 30%) any-grade nonhematologic TEAEs in monotherapy patients were 
diarrhea/colitis (36%), nausea (36%), fatigue (31%) and rash (31%).  Grade 3/4 neutropenia 
occurred in 19% of patients (Forero-Torres et al 2019).  Refer to the parsaclisib IB for further 
details. 
2.2. 
Study Rationale 
This study is designed to evaluate the ORR of parsaclisib in participants with relapsed or 
refractory FL who have received at least 2 prior systemic therapies and who are ineligible for 
HSCT.  Currently no PI3K inhibitor is approved in Japan and consequently there is not a relevant 
comparator for new PI3K inhibitors.  Study INCB 50465-213 will therefore evaluate only 
parsaclisib. 
2.2.1. 
Scientific Rationale for Study Design 
Overall and CRRs usually can be assessed accurately in single-arm as well as randomized 
studies.  Response rates are not considered as important as other endpoints except Phase 2 
studies of novel new agents, in which identification of biologic activity is of interest (Cheson 
et al 2007).  Incorporation of IRC aims to improve objectivity and reliability of clinical data that 
might be participant to observer bias and variability (Amit et al 2011).  Overall survival and PFS 
will be assessed as secondary endpoints as well. 
2.2.2. 
Justification for Dose 
Parsaclisib will be self-administered at a dose of 20 mg QD for 8 weeks, followed by a dose of 
2.5 mg QD until disease progression, death, HSCT (if become eligible), unacceptable toxicity or 
consent withdrawal.  Based on an ex vivo whole blood assay, the 20 mg QD dose provides 
exposure ranging from approximately 2-fold above the IC90 at trough to 19-fold above the IC90 at 
peak.  Furthermore, in the Phase1 Study INCB 50465-101 (Forero-Torres et al 2019) and 
3 Phase 2 studies of participants with relapsed or refractory B-cell malignancies, the majority of 
participants who received this daily dosing regimen and achieved a tumor response did so at the 
first disease assessment (parsaclisib IB and Incyte unpublished data). 
In the Japanese Phase1b dose-escalation Study INCB 50465-111, 14 participants received 
assigned cohort dose of 20 mg QD out of 17 participants) for 8 weeks followed by 20 mg QW.  
The AE profiles and PK parameters are comparable with Study INCB 50465-101. 


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The continuation of parsaclisib at a daily, but lower, dose (2.5 mg) is proposed to provide 
enough exposure (estimated to be approximately 1 × IC90 at peak) to maintain PI3K pathway 
inhibition while minimizing the frequency of late-onset AEs that may lead to study treatment 
withdrawal.  Evaluation of this dosing regimen is ongoing in 3 Phase 2 studies in participants 
with FL (INCB 50465-203), MZL (INCB 50465-204), and mantle cell lymphoma 
(INCB 50465-205).  These studies are done outside of Japan.  Preliminary data from participants 
with FL receiving this regimen suggest that the continuous QD dosing has demonstrated benefits 
in both aggressive and indolent NHL.  The emerging safety profile is consistent with that known 
for parsaclisib.  Detail of dose modification is described in Section 6.5. 
2.3. 
Benefit/Risk Assessment 
Previous 2 Phase 1 studies, INCB 50465-101 and INCB 50465-111 suggested clinical efficacy of 
parsaclisib on participants with relapse and refractory FL.  In Japanese Study INCB 50465-111, 
9 of the 9 treated participants with FL had investigator-assessed CR or PR.  Parsaclisib is 
expected to have reversible effects on immune function.  Combined inhibition may adversely 
affect both B-cell and T-cell immune function with resultant increased risk of a variety of 
infections, including PJP, CMV, and COVID-19.  PI3K inhibitors are known to be associated 
with diarrhea/colitis, pneumonitis, severe cutaneous reactions, and neutropenia.  Similar events 
were observed on the INCB 50465-101 study and 50465-111 study.  We expect to see the 
consistent efficacy and manageable AE with revised dosing regimen.  Also, given the similar PK 
parameters on parsaclisib in Japanese vs non-Japanese participants, we would expect similar 
results of INCB 50465-203 study.  More detailed information about the known and expected 
benefits and risks and reasonably expected AEs of parsaclisib may be found in the parsaclisib IB. 


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3. 
OBJECTIVES AND ENDPOINTS 
Table 5 presents the objectives and endpoints. 
Table 5: 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To assess the efficacy of parsaclisib in terms of 
ORR in participants with relapsed or refractory 
FL. 
ORR, defined as the percentage of participants 
with a CR or PR as defined by revised response 
criteria for lymphomas (Cheson et al 2014), as 
determined by an IRC. 
Secondary 
To assess CRR. 
CRR, defined as the percentage of participants 
with a CR as defined by revised response criteria 
for lymphomas (Cheson et al 2014), as 
determined by an IRC. 
To assess DOR. 
DOR, defined as the time from first documented 
evidence of CR or PR until disease progression or 
death from any cause among participants who 
achieve an objective response, as determined by 
radiographic disease assessment provided by an 
IRC. 
To assess PFS. 
PFS, defined as the time from the date of the first 
dose of study treatment until the earliest date of 
disease progression, as determined by 
radiographic disease assessment provided by an 
IRC, or death from any cause. 
To assess OS. 
OS, defined as the time from the date of the first 
dose of study treatment until death from any 
cause. 
To assess best percentage change in target lesion 
size. 
Best percentage change in target lesion size from 
baseline, where target lesion size is measured by 
the sum of the product of the diameters of all 
target lesion sizes. 
To characterize the safety and tolerability of 
parsaclisib. 
Safety and tolerability assessed by monitoring the 
frequency and severity of AEs; includes 
performing physical examinations and collecting 
vital signs, 12-lead ECGs, and clinical laboratory 
data. 


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4.2. 
Overall Study Duration 
The study begins when the first participant signs the ICF. 
The end of the study (Section 8.9) will occur when all participants have discontinued from the 
study (see Section 7) or have completed at least 12 months of study participation (starting from 
the first dose of study treatment).  It is estimated that the study will take approximately 1.0 year 
to accrue 40 participants, and that the final analysis will be performed no later than 2 years after 
the first dose of study treatment is administered to the last participant treated.  If by the end of 
the study there remains at least 1 participant still on study treatment for at least 12 months, the 
participant(s) may continue treatment.  At this point, a database lock of the study may occur to 
allow the analysis of the study data.  See Section 6.7 for treatment after the end of the study. 
4.3. 
Study Termination 
The investigator retains the right to terminate study participation at any time, according to the 
terms specified in the study contract.  The investigator/head of study site is to notify the IRB/IEC 
in writing of the study's completion or early termination, send a copy of the notification to the 
sponsor or sponsor's designee, and retain 1 copy for the site study regulatory file. 
The investigator retains the right to terminate study participation at any time, according to the 
terms specified in the study contract.  The investigator/head of the study site (Japan) is to notify 
the IRB/IEC in writing of the study's completion or early termination, send a copy of the 
notification to the sponsor or sponsor's designee, and retain 1 copy for the site study regulatory 
file. 
The sponsor may terminate the study electively, if, for example, required by regulatory decision 
or upon advice of the IDMC.  If the study is terminated prematurely, the sponsor will notify the 
investigators/head of the study site, the IRBs and IECs, and regulatory bodies of the decision and 
reason for termination of the study.  The IDMC will recommend termination of the study if 
warranted, as described in IDMC charter. 
For Japan, the decision from the sponsor will be via the head of the study site(s) who will notify 
the investigators and the IRBs of the decision and reason for termination of the study. 


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5. 
STUDY POPULATION 
Deviations from eligibility criteria are not allowed because they can potentially jeopardize the 
scientific integrity of the study, regulatory acceptability, and/or participant safety.  Therefore, 
adherence to the criteria as specified in the Protocol is essential.  Prospective approval of 
Protocol deviations to recruitment and enrollment criteria, also known as Protocol waivers or 
exemptions, are not permitted. 
5.1. 
Inclusion Criteria 
Participants are eligible to be included in the study only if all of the following criteria apply: 
1. Male or female Japanese participant who must be ≥ 18 years of age at the time of signing 
the ICF. 
2. Ability to comprehend and willingness to sign a written ICF and comply with all study 
visits and procedures. 
Note:  For participants under 20 years old, those whose parent/legal guardian is 
willing/able to comply with study requirements and understand/sign the ICF.  Participants 
themselves must sign the ICF form. 
3. Histologically confirmed, relapsed or refractory, FL Grade 1, 2, and 3a. 
4. Ineligible for HSCT. 
5. Must have been treated with at least 2 prior systemic therapies for FL. 
6. Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy 
(defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the LD and ≥ 1.0 cm in 
the LPD, respectively) as assessed by CT or MRI. 
7. Participants must be willing to undergo an incisional, excisional, or core needle lymph 
node or tissue biopsy or provide a lymph node or tissue biopsy collected after the 
completion of last therapy.  An earlier archived lymph node or tissue biopsy is acceptable 
if hospitalization is required for biopsy (eg, no superficial lymph node) and SUVmax by 
FDG-PET is < 14. 
8. ECOG performance status 0 to 2. 
9. Life expectancy ≥ 12 weeks. 


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10. Adequate hematologic, hepatic, and renal function (values must not be achieved with 
growth factors): 
a. ANC ≥ 1.0 × 109/L. 
b. Hemoglobin ≥ 8.0 g/dL. 
c. Platelet count ≥ 50 × 109/L. 
d. Total bilirubin ≤ 1.5 × ULN.  Participants with documented history of Gilbert's 
syndrome and in whom total bilirubin elevations are accompanied by elevated 
indirect bilirubin are eligible. 
e. ALT/AST ≤ 2.5× ULN or ≤ 5 × ULN in the presence of liver involvement. 
f. Calculated creatinine clearance ≥ 40 mL/min by the Cockcroft-Gault Equation or the 
estimated glomerular filtration rate ≥ 40 mL/min/1.73 m2 using the Modification of 
Diet in Renal Disease formula. 
11. Willingness to avoid pregnancy or fathering children based on the criteria below: 
a. Woman of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or 
bilateral oophorectomy OR ≥ 12 months of amenorrhea and > 50 years of age after 
cessation of all exogenous hormonal treatments). 
b. Woman of childbearing potential who has a negative serum pregnancy test and who 
agrees to take appropriate precautions to avoid pregnancy (with at least 99% 
certainty, see Appendix A) from screening through safety follow-up.  Permitted 
methods that are at least 99% effective in preventing pregnancy should be 
communicated to the participant and their understanding confirmed. 
c. Man who agrees to take appropriate precautions to avoid fathering children (with at 
least 99% certainty, see Appendix A) from screening through at least 93 days after 
the last dose of study treatment.  Permitted methods that are at least 99% effective in 
preventing pregnancy should be communicated to the participant and their 
understanding confirmed.  Participant should refrain from donating sperm from the 
start of the study treatment administration until 93 days after discontinuing study 
treatment. 
Note:  Approximately 18 participants with history of ASCT will be involved. 
5.2. 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. Known histological transformation from indolent NHL to DLBCL 
2. History of central nervous system lymphoma (either primary or metastatic). 
3. Prior treatment with the following: 
a. Selective PI3Kδ or pan-PI3K inhibitors (eg, idelalisib, copanlisib, duvelisib, etc). 
b. Bruton's tyrosine kinase inhibitor (eg, ibrutinib). 
4. Allogeneic SCT within the last 6 months, or autologous SCT within the last 
3 months before the date of study treatment administration. 
5. Active graft-versus-host disease. 


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6. Use of immunosuppressive therapy within 28 days of the date of study treatment 
administration.  Immunosuppressive therapy includes, but is not limited to, cyclosporine 
A, tacrolimus, or high-dose corticosteroids.  Participants receiving corticosteroids must 
be at a dose level ≤ 10 mg/day (prednisolone or equivalent) within 7 days of the date of 
study treatment administration. 
7. Receipt of anticancer medications or investigational drugs within the following 
intervals before the date of study treatment administration: 
a. < 10 weeks from completion of any radio- or toxin-immunoconjugates. 
b. < 6 weeks for mitomycin-C or nitrosoureas. 
c. < 4 weeks for immunotherapy. 
d. < 3 weeks for radiotherapy. 
e. < 2 weeks for any investigational agent or other anticancer medications. 
8. Prior treatment-related toxicities have not resolved to ≤ Grade 1 prior to study treatment 
administration except for stable chronic toxicities (≤ Grade 2) not expected to resolve 
(eg, stable Grade 2 peripheral neurotoxicity). 
9. Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, 
immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor 
embolization). 
10. Use or expected use during the study of any prohibited medications (see Section 6.6.3), 
including potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever 
is longer) before the date of study treatment administration. 
11. Significant concurrent, uncontrolled medical condition including, but not limited to, 
renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, 
cerebral, or psychiatric disease. 
12. Current or previous other malignancy within 3 years of study entry, except cured basal or 
squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, 
carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without 
sponsor approval. 
13. History of stroke or intracranial hemorrhage within 6 months of the date of study 
treatment administration. 
14. Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or 
antiviral treatment, and exposure to a live vaccine within 30 days of study treatment 
administration. 
15. Known HIV infection or positivity. 
16. Hepatitis B (HBV) or HCV infection:  Participants positive for HBsAg or hepatitis B 
core antibody will be eligible if they are negative for HBV-DNA; these participants 
should be considered for prophylactic antiviral therapy.  Participants positive for 
anti-HCV antibody will be eligible if they are negative for HCV-RNA. 
17. Clinically significant cardiac disease, including unstable angina, acute myocardial 
infarction, and or cardiac conduction issues within 6 months of the date of study 
treatment administration. 


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18. Current New York Heart Association Class II to IV congestive heart failure or 
uncontrolled arrhythmia. 
19. Presence of an abnormal ECG that is clinically meaningful.  Screening QTc interval 
> 450 milliseconds is excluded (corrected by Fridericia).  In the event that a single QTc is 
> 450 milliseconds, the participant may enroll if the average QTc for 3 ECGs is 
< 450 milliseconds. 
20. Unable to swallow and retain oral medication, malabsorption syndrome, disease 
significantly affecting gastrointestinal function, total resection of the stomach or small 
bowel, ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete 
bowel obstruction. 
21. Known hypersensitivity or severe reaction to parsaclisib (IB) or any of the excipients. 
22. History of serious allergic reactions including anaphylaxis and toxic epidermal 
necrolysis. 
23. Inadequate recovery from toxicity and/or complications from a major surgery before 
study treatment administration. 
24. Currently pregnant or breastfeeding. 
25. Any condition that would, in the investigator's judgment, interfere with full participation 
in the study, including administration of study treatment and attending required study 
visits; pose a significant risk to the participant; or interfere with interpretation of study 
data. 
5.3. 
Lifestyle Considerations 
No restrictions are required. 
5.4. 
Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but are 
not subsequently assigned to study treatment in the study. 
Tests with results that fail eligibility requirements may be repeated once during screening if the 
investigator believes the result to be in error.  Additionally, a participant who fails screening may 
repeat the screening process 1 time if the investigator believes that there has been a change in 
eligibility status.  For screening assessments that are repeated, the most recent available result 
before treatment assignment will be used to determine eligibility.  Participants who rescreen 
must reconsent and be assigned a new participant number. 
5.5. 
Replacement of Participants 
No participants will be replaced at any time during this study. 
5.6. 
Data Monitoring Committee 
Preplanned analyses of safety will be provided to an independent DMC as specified in the DMC 
charter.  The DMC will review safety data of the ongoing study approximately 8 weeks after the 
first 10 participants have been treated.  In addition, the DMC will make recommendations to the 


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6.2.3. 
Instruction to Participants for Handling Parsaclisib 
The participant must be instructed in the handling of parsaclisib as follows: 
• To store study treatment at room temperature. 
• To remove from the study treatment bottle only the number of tablets needed at the 
time of administration. 
• Not to remove doses in advance of the next scheduled administration. 
• To make every effort to take doses on schedule. 
• To report any missed doses. 
• To keep parsaclisib in a safe place and out of reach of children. 
• To bring all used and unused study treatment kits to the site at each visit. 
The investigator, investigational drug storage manager (Japan), or designee is responsible for 
study treatment accountability, reconciliation, and record maintenance (ie, receipt, reconciliation, 
and final disposition records).  Inventory and accountability records must be maintained and be 
readily available for inspection by the study monitor and open to inspection at any time by any 
applicable regulatory authorities.  The investigator, investigational drug storage manager, or 
designee must maintain records that document: 
• Delivery of study drug to the study site. 
• Inventory of study drug at the site. 
• Participant use of the study drug, including tablet counts from each supply dispensed. 
• Return of study drug to the investigator, investigational drug storage manager (for 
Japan) or designee by participants. 
The investigational product must be used only in accordance with the Protocol.  The investigator 
will also maintain records adequately documenting that the participants were provided the 
specified study drug.  These records should include dates, quantities, and any available batch or 
serial numbers or unique code numbers assigned to the investigational product and study 
participants. 
Completed accountability records will be archived by the site.  The investigator, investigational 
drug storage manager, or designee will be expected to collect and retain all used, unused, and 
partially used containers of study drug until verified by the study monitor (unless otherwise 
agreed to by the sponsor).  At the conclusion of the study, the investigator, investigational drug 
storage manager, or designee will oversee shipment of any remaining study drug back to the 
sponsor or its designee for destruction according to institutional SOPs.  If local procedures 
mandate on-site destruction of investigational supply, the site should (where local procedures 
allow) maintain the investigational supply until the study monitor inspects the accountability 
records in order to evaluate compliance and accuracy of accountability by the investigative site.  
At sites where the study drug is destroyed before monitor inspection, the monitors rely on 
documentation of destruction per the site SOP. 


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Further guidance and information for the final disposition of unused study treatments are 
provided in the Pharmacy Manual. 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding 
Not applicable. 
6.4. 
Study Treatment Compliance 
Compliance with all study-related treatments should be emphasized to the participant by the site 
personnel, and appropriate steps should be taken to optimize compliance during the study.  
Compliance with parsaclisib will be calculated by the sponsor based on the drug accountability 
documented by the site staff and monitored by the sponsor/designee (tablet counts).  Participants 
will be instructed to keep a daily diary to record dosing compliance and bring the diary plus all 
study treatments with them to the study visits for site personnel to conduct tablet counts to assess 
study treatment accountability.  The drug accountability documentation will be used by the 
sponsor to calculate treatment compliance. 
6.5. 
Dose Modifications 
Dose modification guidance for AEs that have been previously observed in participants receiving 
parsaclisib or are potential class-effect AEs are provided (see Table 7).  The starting dose and 
dose reduction levels of parsaclisib are provided (see Table 8).  Individual decisions regarding 
dose interruption and reduction should be made using clinical judgment and in consultation with 
the sponsor's medical monitor, taking into account relatedness of the AE to the study treatment 
and the participant's underlying condition.  Adverse events that have a clear alternative 
explanation or transient (≤ 72 hours) abnormal laboratory values without associated clinically 
significant signs or symptoms may be exempt from dose-reduction guidelines. 
Table 7: 
Guidelines for Interruption and Restarting of Study Drug 
ADVERSE EVENT 
ACTION TAKEN 
Chemistry 
• AST and/or ALT is Grade 3 (> 5.0 
× ULN). 
Note:  In participants with liver metastasis–
related elevations at baseline, contact 
sponsor to discuss clinical management and 
possible dose reductions. 
Step 1:  Interrupt parsaclisib and monitor weekly until the 
toxicity has resolved to ≤ Grade 1. 
Step 2:  Restart parsaclisib at next lower dose with medical 
monitor approval.  Monitor as clinically indicated. 


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Table 7: 
Guidelines for Interruption and Restarting of Study Drug (Continued) 
ADVERSE EVENT 
ACTION TAKEN 
Hematology 
• Grade 3 ANC (< 1.0 × 109/L).
• Platelet count is Grade 2 (50 to
< 75 × 109/L) for participants who enrolled
with platelets > 100 × 109/L.
• Platelet count is Grade 3 (< 50 × 109/L) for
participants who enrolled with platelets
≤ 100 × 109/L.
Step 1:  Interrupt parsaclisib up to 14 days until the toxicity has 
resolved to ≤ Grade 1 or pretherapy baseline.  For Grade 3 ANC, 
monitor at least weekly. 
Step 2:  Restart parsaclisib at same dose; monitor as clinically 
indicated. 
• Grade 4 ANC (< 0.5 × 109/L).
• Grade 3 or Grade 4 febrile neutropenia.
• Platelet count is Grade 4 (< 25 × 109/L).
Step 1:  Interrupt parsaclisib up to 14 days until the toxicity has 
resolved ≤ Grade 2. (Monitor ANC at least weekly.) 
Step 2:  Restart parsaclisib at same dose.  Monitor as clinically 
indicated.  If recurs, start at next lower dose. 
Other toxicities 
• Diarrhea (Grade 1).
Step 1:  Treat with antimotility agents (eg, 2 mg loperamide 
followed by 2 mg every 4 hours or after every unformed stool) 
and initiate supportive care (see Section 6.5.1).  Monitor 
approximately every 48 hours until resolved.  If not improved 
after 48 hours, treat per guidance for Grade 2.  
• Diarrhea (Grade 2).
Step 1:  Interrupt parsaclisib.  Perform work-up for infection 
(including CMV, C. difficile, etc) immediately.  Initiate or 
continue supportive care (see Section 6.5.1).  Monitor 
approximately every 48 hours until resolution. 
Step 2:  If improved within 48 hours and/or infection* is 
confirmed, restart parsaclisib at the same schedule and dose after 
resolved to ≤ Grade 1 and continue to monitor. 
*For infectious diarrhea/colitis, follow institutional
standard-of-care guidelines and restart parsaclisib according to 
clinical judgement after resolved to ≤ Grade 1.  Consult with 
medical monitor if needed.
Step 3:  If not improved within 48 hours and infection is ruled 
out, start oral steroids, or consider IV steroids if participant is 
being given IV fluids.  If no improvement with oral steroids, 
switch to IV steroids. 
Step 4:  When diarrhea resolves to ≤ Grade 1, continue 
supportive care and taper steroids according to institutional 
standard of care.  When taper is complete (eg, no steroid or 
≤ 10 mg/day prednisone or equivalent) and diarrhea is ≤ Grade 1, 
restart parsaclisib at the next lower dose with approval of the 
medical monitor (see Table 8 for dose levels). 
Step 5:  If Grade 2 diarrhea reoccurs, treat per guidance for 
diarrhea (≥ Grade 3)/noninfectious colitis. 
Step 6:  If ≥ Grade 2 diarrhea reoccurs a third time, permanently 
discontinue parsaclisib. 


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Table 7: 
Guidelines for Interruption and Restarting of Study Drug (Continued) 
ADVERSE EVENT 
ACTION TAKEN 
Other toxicities (continued) 
• Diarrhea (≥ Grade 3). 
• Noninfectious colitis (any grade; 
confirmed or suspected). 
Step 1:  Interrupt parsaclisib.  Perform work-up for infection 
(including CMV, C. difficile, etc) immediately.  Initiate or 
continue supportive care (see Section 6.5.1).  Consider 
colonoscopy with biopsy for diarrhea ≥ Grade 3 and/or if 
symptomsa suggestive of colitis.  Monitor every 48 hours until 
resolution. 
Step 2:  If infection* is ruled out, start oral steroids, or consider 
IV steroids if participant is being given IV fluids.  If no 
improvement with oral steroids within 48 hours, switch to IV 
steroids. 
*For infectious diarrhea/colitis, follow institutional standard of 
care guidelines and restart parsaclisib according to clinical 
judgement after resolved to ≤ Grade 1.  Consult with medical 
monitor if needed. 
Step 3:  When diarrhea/colitis resolves to ≤ Grade 1, continue 
supportive care and taper steroids according to institutional 
standard of care.  When taper is complete (eg, no steroid or 
≤ 10 mg/day prednisone or equivalent) and diarrhea/colitis is 
≤ Grade 1, restart parsaclisib as described herein and with 
approval of the medical monitor.  Continue to monitor. 
Parsaclisib 
Dose Modification 
Any dose with QD dosing 
20 mg QW 
20 mg QW 
10 mg QW 
Step 4:  If ≥ Grade 3 diarrhea/colitis (any grade) reoccurs, 
permanently discontinue parsaclisib. 
• Pneumonitis (Grade 1). 
Step 1:  Interrupt parsaclisib until the toxicity has resolved. 
Step 2:  Restart parsaclisib at next lower dose.  Monitor as 
clinically indicated. 
• Pneumonitis (≥ Grade 2). 
Permanently discontinue parsaclisib. 
• Skin toxicity (eg, rash, pruritus, etc, unless 
otherwise specified) (Grade 2-3). 
Step 1:  Interrupt parsaclisib until the toxicity has resolved to 
≤ Grade 1. 
Step 2:  Restart parsaclisib at same dose.  If assessed as related to 
parsaclisib, restart at next lower dose. 
• Exfoliative dermatitis (Grade 1). 
Step 1:  Interrupt parsaclisib until the toxicity has resolved. 
Step 2:  Restart parsaclisib at next lower dose.  Monitor as 
clinically indicated. 
• Exfoliative dermatitis (≥ Grade 2). 
Permanently discontinue parsaclisib. 
• Intestinal perforation (any grade). 
Permanently discontinue parsaclisib. 
• Pneumocystis jiroveci pneumonia 
infection. 
Interrupt parsaclisib.  Permanently discontinue parsaclisib if 
Pneumocystis jiroveci pneumonia infection is confirmed. 


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Table 7: 
Guidelines for Interruption and Restarting of Study Drug (Continued) 
ADVERSE EVENT 
ACTION TAKEN 
Other toxicities (continued) 
• CMV infection. 
Participants with CMV viremia without associated clinical signs 
of CMV infection should be carefully monitored.  Consider 
interrupting parsaclisib for participants with CMV viremia and 
clinical signs of infection until the infection has resolved.  Restart 
parsaclisib reduced by 1 dose level if approved by the medical 
monitor. 
• Varicella zoster infection. 
Interrupt parsaclisib.  Restart parsaclisib only by approval of the 
medical monitor. 
• Any Grade 1 or Grade 2 toxicity unless 
otherwise specified. 
Continue parsaclisib and treat the toxicity; monitor as clinically 
indicated. 
• Any Grade 3 toxicity, if clinically 
significant and not manageable by 
supportive care unless otherwise specified. 
Step 1:  Interrupt parsaclisib up to 14 days until the toxicity has 
resolved to ≤ Grade 1. 
Step 2:  Restart parsaclisib at same dose.  If assessed as related to 
parsaclisib, restart at next lower dose.  If interrupted for 
> 14 days, contact the medical monitor for approval to restart 
parsaclisib.  Monitor as clinically indicated. 
• Any recurrent Grade 3 toxicity after 
2 dose reductions. 
Discontinue parsaclisib administration and follow-up per 
Protocol.  Exceptions require approval of sponsor. 
• Any other Grade 4 toxicity. 
Discontinue parsaclisib administration and follow-up per 
Protocol.  Exceptions require approval of sponsor. 
CMV = cytomegalovirus; IV = intravenous; PCR = polymerase chain reaction. 
a Diarrhea accompanied by abdominal pain and/or mucus or blood in stool. 
Table 8: 
Dose Levels for Parsaclisib 
Timepoint 
Dose 
Starting dose 
20 mg QD for 8 weeks 
(Day 1 through Day 56) 
First dose reduction 
10 mg QD 
Second dose reduction 
5 mg QD 
Week 8 (Day 57) onward 
2.5 mg QDa 
First dose reduction 
1 mg QD 
Second dose reduction 
NA 
a All participants will receive 2.5 mg QD at Week 8 (Day 57) regardless of prior dose level unless dose was 
modified due to diarrhea/colitis guidelines. 


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6.5.1. 
Supportive Care Guidelines for Diarrhea/Colitis 
Participants should be informed to immediately report to the investigator any event of diarrhea.  
Treatment with parsaclisib may be interrupted or modified according to the guidelines in Table 7 
to allow for resolution of diarrhea/colitis. 
Participants should receive appropriate supportive care measures as deemed necessary by the 
investigator.  For any Grade ≥ 1 diarrhea, participants should be advised to drink liberal 
quantities of clear fluids.  If sufficient oral fluid intake is not feasible, fluid and electrolytes 
should be substituted via IV infusion.  Participants should try to eat 5 to 6 small meals per day; 
low-fat, high-protein foods; and cooked instead of raw vegetables.  Participants may supplement 
their diet with bananas, rice, applesauce, and toast to reduce the number of bowel movements 
and may also try crackers, gelatin, noodles, or oatmeal.  Participants should avoid fried, fatty, 
greasy, or spicy foods; milk, milk products, and acidic drinks; high-fiber foods and foods that 
cause gas; and alcohol, caffeine, and herbal supplements (Coutré et al 2015). 
For each occurrence, attempts should be made to rule out other causes, such as metastatic disease 
or bacterial or viral infection (including CMV), which might require additional supportive care. 
It may be necessary to perform conditional procedures such as colonoscopy with biopsy as part 
of evaluation of the event.  Note that several courses of steroid tapering may be necessary as 
symptoms may worsen when the steroid dose is decreased. 
Participants should be carefully monitored for signs and symptoms of enterocolitis (such as 
diarrhea, abdominal pain or cramping, blood or mucus in stool, with or without fever) and of 
bowel perforation (such as peritoneal signs and ileus). 
6.5.2. 
Supportive Care Guidelines for Neutropenia and Thrombocytopenia 
Neutropenia and thrombocytopenia appear to be PI3Kδ class-effect toxicities.  Investigators 
should ensure that participants understand the need to seek medical care when they have 
conditions that could become life-threatening in the presence of cytopenias (eg, neutropenic 
fever or bleeding with low platelets).  Participants should be instructed to report immediately any 
signs of infection, unexpected bleeding, or sudden, extremely painful headaches. 
6.5.3. 
Definition for Immune-Related Adverse Events 
Adverse events of a potential immunologic etiology, or irAEs, may be defined as an AE 
consistent with an immune phenomenon associated with study treatment exposure after all other 
etiologies have been eliminated.  Immune-related AEs may be expected based on previous 
experience with parsaclisib and other PI3K inhibitors.  Special attention should be paid to AEs 
that may be suggestive of potential irAEs.  Based on emerging data from the ongoing Study 
INCB 50465-101, most irAEs occur after the first 9 weeks of study treatment administration.  
However, an irAE could occur at any time.  Suspected irAEs should be discussed with the 
medical monitor when possible. 
Participants should receive appropriate supportive care measures as deemed necessary by the 
treating investigator.  Suggested supportive care measures for the management of drug-related 
AEs with potential immunologic etiology are outlined in Table 7 and Section 6.5.1.  For each 
AE, attempts should be made to rule out other causes, including but not limited to metastatic 
disease or bacterial or viral infection, which might require specific supportive care. 


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6.5.4. 
Criteria and Procedures for Dose Interruptions 
Safety concerns should be discussed with the sponsor immediately upon occurrence or awareness 
to determine if the participant should continue or discontinue study treatment. 
Treatment with parsaclisib may be delayed up to 14 days to allow for resolution of 
toxicity.  Participants may resume treatment if no medical condition or other circumstance exists 
that, in the opinion of the investigator, would make the participant unsuitable for further 
participation in the study.  The treating investigator should contact the sponsor to discuss the 
case of any participant whose treatment has been delayed for more than 14 days before restarting 
treatment with parsaclisib. 
6.6. 
Concomitant Medications and Procedures 
All concomitant medications and treatments must be recorded in the eCRF.  Any prior 
medication received up to 30 days before the date of study treatment administration (Day 1) will 
be recorded in the eCRF.  Any addition, deletion, or change in the dose of these medications will 
also be recorded.  Concomitant treatments and/or procedures that are required to manage a 
participant's medical condition during the study will also be recorded in the eCRF.  The medical 
monitor should be contacted if there are any questions regarding concomitant or prior therapy. 
6.6.1. 
Pneumocystis Jirovecii Prophylaxis 
All participants are required to receive a standard PJP prophylaxis regimen determined by the 
investigator.  Examples of standard PJP prophylaxis therapies for this population include 
trimethoprim-sulfamethoxazole, atovaquone, diaphenylsulfone with or without pyrimethamine, 
and pentamidine (diaphenylsulfone and pentamidine are not approved for PJP prophylaxis in 
Japan) (NCCN 2020).  Due to reports of cross-sensitivity between sulfonamides and dapsone, all 
participants who have a known or suspected allergy to sulfonamides must receive atovaquone for 
PJP prophylaxis.  Trimethoprim-sulfamethoxazole or atovaquone can be used for PJP 
prophylaxis in this study.  Prophylaxis should be given while participants are receiving study 
treatment and should continue for 2 to 6 months after the last dose of study treatment. 
The prophylactic agents will be obtained from commercial supplies and will be reimbursed by 
the sponsor.  Investigators are responsible for ensuring that participants receive commercially 
available supplies of the selected prophylactic agents as required per Protocol.  The sponsor may 
provide prophylactic agents where required by applicable law or regulation or under other 
limited circumstances when a participant may not otherwise have access to these therapies.  The 
contents of the label will be in accordance with all applicable regulatory requirements.  Further 
details are available in the Pharmacy Manual. 


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6.6.2. 
Restricted Medications and Procedures 
• Use of systemic corticosteroid doses ≤ 10 mg/day prednisone (or equivalent) is 
permitted but discouraged from the screening visit through EOT. 
• Short courses of systemic corticosteroid doses > 10 mg/day prednisolone or 
equivalent are permitted only in the case of severe or life-threatening complications 
that cannot be controlled with other drugs, but are otherwise discouraged from the 
screening visit through EOT. 
• Use of weak or moderate inducers or inhibitors of CYP3A4 (see Appendix B and 
consult your local pharmacist) is discouraged, and investigators should seek other 
options where possible. 
• For participants receiving parsaclisib, P-glycoprotein substrates of clinical relevance 
should be used with caution (ie, aliskiren, ambrisentan, colchicine, dabigatran 
etexilate, digoxin, everolimus, fexofenadine, imatinib, lapatinib, maraviroc, nilotinib, 
posaconazole, ranolazine, saxagliptin, sirolimus, sitagliptin, talinolol, tolvaptan, 
topotecan). 
• Localized radiotherapy will be permitted if administered as treatment for pain or 
impending compression fractures and with prior approval of the medical monitor. 
6.6.3. 
Prohibited Medications and Procedures 
• Use of potent inducers and inhibitors of CYP3A4 are prohibited (see Appendix B and 
consult your local pharmacist).  Based on the low overall bioavailability of topical 
ketoconazole, there are no restrictions on topical ketoconazole. 
• Apart from the study treatments, the use of any anticancer medications as described 
(see Section 5.2) through the 30-day follow-up is prohibited. 
• Exposure to a live vaccine within 30 days of study treatment through 3 months after 
the last dose of INCB050465. 
6.7. 
Treatment After the End of the Study 
At the end of the study as defined in Section 8.9, participants who have completed at least 
12 months of study participation (starting from the first dose of study treatment), who remain on 
active study treatment, and who have no evidence of PD may continue treatment.  Any 
remaining participants may continue to receive study treatment and be seen by the investigator 
per usual standard of care for this participant population.  In addition, the investigator will be 
expected to monitor for and report any SAEs, ECIs, and pregnancies, as detailed in 
Section 9.  The participants is considered on study until such time that they meet any of the 
discontinuation criteria and written notification is given to the sponsor. 


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7. 
DISCONTINUATION OF STUDY TREATMENT AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1. 
Discontinuation of Study Treatment 
The decision to discontinue study treatment will not constitute study completion.  In the event 
that study treatment is discontinued, the treatment period will be considered complete, and 
follow-up periods will begin. 
7.1.1. 
Reasons for Discontinuation 
Participants must be discontinued from study treatment for the following reasons: 
• The participant has died. 
• The participant has experienced an unacceptable toxicity defined as follows: 
− Occurrence of an AE that is related to study treatment that, in the judgment of the 
investigator or the sponsor's medical monitor, compromises the participant's 
ability to continue study-specific procedures or is considered to not be in the 
participant's best interest. 
− Persistent AE requiring a delay of therapy for more than 2 weeks (14 days) unless 
a greater delay has been approved by the sponsor. 
• The participant is unable to tolerate study treatment. 
• The participant has an objective radiographic tumor response of PD/PMD. 
• Further participation would be injurious to the participant's health or well-being, in 
the investigator's medical judgment. 
• The participant becomes pregnant. 
• Informed consent is withdrawn.  Note:  Consent withdrawn means that the participant 
can no longer be followed.  Participants may choose to discontinue study treatment 
and remain in the study to be followed for disease progression and survival per the 
schedule of assessments. 
• The participant is considered lost-to-follow-up when they repeatedly fail to return for 
scheduled visits and is unable to be contacted by the study site (eg, after 3 telephone 
calls and/or a certified letter or local equivalent). 
• The study is terminated by the sponsor. 
• The study is terminated by the local health authority, IRB, or IEC. 
Participants may be discontinued from study treatment in the following situation: 
• If a participant is noncompliant with study procedures or study treatment 
administration in the investigator's opinion, then the sponsor should be consulted for 
instruction on handling the participant. 


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7.1.2. 
Discontinuation Procedures 
In the event that the decision is made to permanently discontinue the study treatment, the EOT 
visit should be conducted.  Reasonable efforts should be made to have the participant return for a 
follow-up visit.  These visits are described in Table 3 and Table 4.  The last date of the last dose 
of study drug and the reason for discontinuation of study treatment will be recorded in the eCRF. 
If a participant is discontinued from study treatment: 
• The study monitor or sponsor must be notified. 
• The reason(s) for discontinuation must be documented in the participant's medical 
record and the primary reason for withdrawal must be included in the eCRF. 
• The EOT visit should be performed and date recorded. 
• The status of the participant should be updated to EOT in the IWRS. 
• Participants must be followed for safety until the time of the follow-up visit or until 
study drug–related toxicities resolve, return to baseline, or are deemed irreversible, 
whichever is longest. 
If the participant discontinues study treatment and actively withdraws consent for collection of 
follow-up data (safety follow-up or disease assessment), then no additional data collection 
should occur; however, participants will have the option of withdrawing consent for study 
treatment but continuing in the follow-up period of the study for safety/efficacy and survival per 
the schedule of assessments. 
7.2. 
Participant Withdrawal From the Study 
A participant may withdraw from the study at any time at their own request, or may be 
withdrawn at any time at the discretion of the investigator for safety, behavioral, compliance, or 
administrative reasons. 
If the participant withdraws consent for disclosure of future information, the sponsor may retain 
and continue to use any data collected before such a withdrawal of consent. 
If a participant withdraws from the study, they may request destruction of any samples taken and 
not tested, and the investigator must document this in the site study records. 
See Table 3 for data to be collected at the time of study withdrawal and follow-up and for any 
further evaluations that need to be completed. 
7.3. 
Lost to Follow-Up 
A participant will be considered lost to follow-up if they repeatedly fail to return for scheduled 
visits and is unable to be contacted by the study site. 


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The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
• The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible and counsel the participant on the importance of maintaining the 
assigned visit schedule and ascertain whether or not the participant wishes to and/or 
should continue in the study. 
• Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls and, if necessary, a certified letter to the participant's last known mailing address 
or local equivalent methods).  These contact attempts should be documented in the 
participant's medical record. 
• Should the participant continue to be unreachable, they will be considered to have 
withdrawn from the study. 
8. 
STUDY ASSESSMENTS AND PROCEDURES 
8.1. 
Administrative and General Procedures 
8.1.1. 
Informed Consent Process 
• The investigator or their representative will explain the nature of the study to the 
participant or their legally authorized representative and answer all questions 
regarding the study. 
− Informed consent must be obtained before any study-related procedures are 
conducted, unless otherwise specified by the Protocol. 
− Informed consent must be obtained using the IRB/IEC-approved version in a 
language that is native and understandable to the participant.  A template will be 
provided by the sponsor or its designee.  The sponsor or its designee must review 
and acknowledge the site-specific changes to the ICF template.  The ICF must 
include a statement that the sponsor or its designee and regulatory authorities have 
direct access to participant records. 
− The ICF must contain all required elements and describe the nature, scope, and 
possible consequences of the study in a form understandable to the study 
participant. 
• Participants must be informed that their participation is voluntary.  Participants or 
their legally authorized representative will be required to sign a statement of informed 
consent that meets the applicable requirements and regulations for the country in 
which the study is being conducted as well as the IRB/IEC or study center. 
• The participant must be informed that their personal study-related data will be used 
by the sponsor in accordance with local data protection laws.  The level of disclosure 
must also be explained to the participant. 


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• Stem cell transplant:  In participants undergoing > 1 SCT, each SCT (autologous or 
allogeneic) should be considered a new line of therapy regardless of whether the 
conditioning regimen used is the same or different. 
Note:  A therapy administered before an SCT, the subsequent SCT, and planned maintenance 
therapy after the SCT is considered 1 line of therapy. 
8.2. 
Efficacy Assessments 
8.2.1. 
Computed Tomography Scan or Magnetic Resonance Imaging 
Participants will undergo a diagnostic-quality CT or MRI to evaluate measurable disease.  If CT 
is not available, is not practicable, or is contraindicated, then an MRI may be substituted.  Every 
effort must be made to use the same modality for disease assessment throughout the study for 
each individual participant.  Lesion assessment must be done for the neck, chest, abdomen, and 
pelvis. 
If CT/MRI assessment was performed as standard of care before signing of the ICF but within 
28 days of Day 1, then the results from that assessment must be recorded in the eCRF if used in 
lieu of a study-specific assessment. 
The disease assessment schedule also applies to those participants who discontinue study 
treatment for reasons other than disease progression until disease progression, start of new 
anticancer therapy, withdrawal of consent, end of the study, or death, whichever occurs first.  
Imaging should not be delayed for interruption of study treatment. 
No further CT/MRI is required as per Protocol-defined timepoint after all study participants have 
completed at least 12 months of study participation (starting from the first dose of study 
treatment). 
8.2.2. 
Bone Marrow Examination 
Bone marrow examination is required as a baseline assessment except in the following 
circumstances: 
• Participant had a bone marrow examination performed as per standard of care within 
approximately 60 days from the first dose of study treatment. 
• Participant had a bone marrow examination performed after the last treatment for 
NHL and the results showed lymphoma involvement of the bone marrow. 
Subsequently, bone marrow examination will be performed and the sample(s) sent to a local 
histopathology laboratory to confirm CR, or as clinically indicated.  If the bone marrow does not 
have lymphoma involvement at baseline, a repeat marrow examination is not required to confirm 
indication of CR on imaging.   
All bone marrow examinations should include a unilateral aspiration and biopsy, when feasible. 
The pathology report result from the bone marrow examination will be captured in the eCRF. 
Note:  Bone marrow biopsies and aspirates collected at screening should be evaluated locally.  
These materials are not to be sent to the central laboratory or the sponsor. 


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All SAEs will be recorded and reported to the sponsor or designee within 24 hours.  The 
investigator will submit any updated SAE data to the sponsor within 24 hours of it being 
available. 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts.  All SAEs and nonserious AESI (as defined in Section 9.5.1) will 
be followed until resolution, stabilization, the event is otherwise explained, or the participant is 
lost to follow-up (as defined in Section 7.3). 
8.3.2. 
Physical Examinations 
Physical examinations must be performed by a medically qualified individual, such as a licensed 
physician, physician's assistant, or an advanced registered nurse practitioner, as local law 
permits.  Abnormalities identified after the first dose of study treatment constitute an AE if they 
are considered clinically meaningful, induce clinical signs or symptoms, require concomitant 
therapy, or require changes in study drug.  Investigators should pay special attention to clinical 
signs related to previous serious illnesses. 
At the screening and EOT visit, a comprehensive physical examination should be conducted.  
The comprehensive physical examination will include height and assessment(s) of the following 
organ or body systems:  skin; head, eyes, ears, nose, and throat; thyroid; lungs; cardiovascular 
system; abdomen (liver, spleen); extremities; and lymph nodes; as well as a brief neurological 
examination. 
During the study, participants will be assessed by the investigator or medically qualified 
designee per institutional standard of care as disease specific physical examination.  These 
assessments should be an evaluation as indicated by participant symptoms, AEs, or other 
findings and documented on the AE eCRF. 
8.3.3. 
Vital Signs 
Vital sign measurements (to be taken before blood collection for laboratory tests), include blood 
pressure, pulse, respiratory rate, and body temperature.  If vital signs cannot be taken before 
blood collection for laboratory tests, there must be a minimum of 30 minutes from the 
completion of the blood collection procedures to the beginning of the vital signs collection.  
Blood pressure and pulse will be taken with the participant in the recumbent, semirecumbent, or 
sitting position after 5 minutes of rest.  Weight will also be assessed at each study visit.  
Clinically notable abnormalities that are considered clinically significant in the judgment of the 
investigator are to be reported as AEs. 
8.3.4. 
Electrocardiograms 
12-lead ECG will be obtained as outlined in the SoA (see Table 3).  All 12-lead ECGs will be 
performed with the participant in a recumbent or semirecumbent position after 5 minutes of rest.  
Baseline ECGs will be obtained during screening using a single measurement but can be 
performed in triplicate if the single QTc measurement is > 450 milliseconds (corrected by 
Fridericia; see Section 5.2). 
Electrocardiograms will also be obtained during the Day 1 visit (triplicate measurements) before 
the participant receives the first dose of study drug.  Triplicate ECGs will be performed predose 


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and 1.5 hours (± 15 minutes) after receiving study treatment at the Week 4 visit.  When triplicate 
ECGs are being obtained, individual measurements should be performed 5 minutes (± 3 minutes) 
apart.  All 12-lead ECGs obtained at subsequent timepoints (single measurements) will be 
compared with the baseline 12-lead ECGs as follows: 
• For ECG morphology, all postdose ECG recordings will be compared with Day 1 
predose ECGs. 
• For the calculation of changes in cardiac intervals (eg, QT interval), the intervals 
from the screening and Day 1 predose (triplicate) ECGs will be computed and 
averaged and used as the baseline for comparison of all postdose intervals. 
If a single measurement demonstrates a QTc interval > 500 milliseconds, 2 more ECGs should 
be obtained over a brief period, and the averaged QTc intervals should be used to determine 
whether the study treatment should be interrupted. 
Twelve-lead ECGs will be acquired using an ECG analysis system with analysis and printing 
capabilities.  The 12-lead ECGs will be interpreted by the investigator at the site and will be used 
for immediate participant management.  The decision to include or exclude a participant or 
discontinue a participant's participation in the study based on an ECG is the responsibility of the 
investigator, in consultation with the sponsor's medical monitor, as appropriate.  Twelve-lead 
ECGs that are identified by the investigator as "Abnormal, Clinically Significant" will be sent to 
the sponsor's medical monitor for review. 
Electrocardiogram abnormalities where study exclusion, further cardiovascular investigation, 
and/or prompt action may be necessary depending on the clinical context. 
8.3.5. 
Eastern Cooperative Oncology Group Performance Status 
Eastern Cooperative Oncology Group performance status (Oken et al 1982; see Appendix C) will 
be assessed.  Performance status must be assessed by a medically qualified individual and 
recorded in the eCRF. 
8.3.6. 
Laboratory Assessments 
Blood draws for laboratory assessments will occur at study visits indicated (see Table 4).  
Specific laboratory assessments are provided (see Table 9). 
See Section 9.1 for information regarding laboratory abnormalities that should be recorded as an 
AE in the eCRF.  Additionally, if laboratory values from laboratory assessments performed at the 
institution's local laboratory require a change in participant management (eg, require treatment), 
or are considered clinically significant by the investigator (eg, SAE or AE or dose modification, 
see Section 6.5), then the result(s) of the specific laboratory assessment(s) must be recorded in 
the eCRF. 


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Table 9: 
Required Laboratory Analytes 
Serum Chemistries 
Hematology 
Serology 
Pregnancy Testing 
(Performed Locally) 
Albumin 
Alkaline phosphatase 
ALT 
AST 
Bicarbonate (if applicable) 
Blood urea nitrogen 
C-reactive protein 
Calcium 
Chloride 
Creatinine 
Glucose 
Lactate dehydrogenase 
Phosphate 
Potassium 
Sodium 
Total bilirubin 
Direct bilirubin (if total 
bilirubin is > ULN) 
Indirect bilirubin (if total 
bilirubin is > ULN) 
Total protein 
Uric acid 
Complete blood count, 
including: 
Hemoglobin 
Hematocrit 
Platelet count (absolute)  
Red blood cell count  
White blood cell count 
 
Differential count, 
including: 
Basophils 
Eosinophils 
Lymphocytes 
Monocytes 
Neutrophils 
 
Absolute values must be 
provided for: 
WBC differential 
laboratory results: 
Lymphocytes 
Neutrophils 
HBsAg 
HBsAg antibody 
Hepatitis B core antibody 
HBV-DNA (serology 
positive only) 
HCV antibody 
HCV-RNA 
CMV DNA 
HIV antibody 
Only for female 
participants of 
childbearing potential 
(see Table 4). 
Pregnancy tests 
(serum or urine) 
Note:  Additional tests may be required, as agreed by investigator and sponsor, based on emerging safety data. 
8.3.6.1. 
Chemistry and Hematology 
All chemistry and hematology assessments (see Table 3 and Table 4) will be performed from 
blood samples collected using institutional best practices. 
8.3.6.2. 
Pregnancy Testing 
A serum pregnancy test will be required for all women of childbearing potential (see Section 5.1) 
as shown (see Table 4).  Serum pregnancy and urine pregnancy tests will be performed locally as 
outlined in Table 4.  If a urine pregnancy test is positive, the results should be confirmed with a 
serum pregnancy test. 
If the serum pregnancy test is negative after a urine test was positive, the investigator will assess 
the potential benefit/risk to the participant and determine whether it is in the participant 's best 
interest to resume study drug and continue participation in the study. 
If a pregnancy is confirmed by a serum pregnancy test, see Section 9.7 for reporting 
requirements. 


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Incyte Biosciences Japan GK 
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8.5.3. 
Tissue Biopsies 
Participants must have an available tissue biopsy after the completion of last therapy or be 
willing to undergo a pretreatment tumor biopsy at baseline.  
 
 
 
 
 
If a participant doesn't have a superficial lymph node or tumor and needs hospitalization for the 
purpose of a tissue biopsy, submitting the most recent archived tumor tissue sample is allowed. 
8.6. 
Unscheduled Visits 
Unscheduled visits may be held at any time at the investigator's discretion and appropriate 
clinical and laboratory measurements performed based on AEs or other findings. 
8.7. 
End of Treatment 
There is no predefined EOT.  When the participant permanently discontinues study drug, the 
EOT visit should be conducted.  If the EOT visit coincides with a regular study visit, the EOT 
evaluations will supersede those of that scheduled visit, and the data should be entered in the 
EOT visit in the eCRF.  The participant should be encouraged to return for the follow-up visit. 
8.8. 
Follow-Up 
8.8.1. 
Safety Follow-Up 
The safety follow-up period is the interval between the EOT visit and the scheduled follow-up 
visit, which should occur 30 to 35 days after the EOT visit (or after the last dose of study 
drug/treatment if the EOT visit was not performed).  Adverse events and SAEs must be reported 
up until 1) at least 30 days after the last dose of study drug or the start of a new anti-lymphoma 
therapy or 2) until toxicities resolve, return to baseline, or are deemed irreversible.  Reasonable 
efforts should be made to have the participant return for the follow-up visit and report any AEs 
that may occur during this period. 
If a participant is scheduled to begin a new anti-lymphoma therapy before the end of the safety 
follow-up period, the safety follow-up visit should be performed before a new anti-lymphoma 
therapy is started.  Once a new anti-lymphoma therapy has been initiated, the participant will 
move into the survival follow-up period. 


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9. 
ADVERSE EVENTS:  DEFINITIONS AND PROCEDURES FOR 
RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING 
9.1. 
Definition of Adverse Event 
Adverse Event Definition 
• An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or 
not considered drug-related. 
• An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory 
finding), symptom, or disease (new or exacerbated) temporally associated with the use of study 
treatment. 
Additional Guidance for Events Meeting the Adverse Event Definition  
• Any safety assessments (eg, ECG, vital signs measurements), including those that worsen from 
baseline, considered clinically significant in the medical and scientific judgment of the investigator 
(ie, not related to progression of underlying disease) are to be reported as an AE. 
• Abnormal laboratory test results constitute an AE if they are considered clinically meaningful, induce 
clinical signs or symptoms, require concomitant therapy, or require changes in study drug.  
Whenever possible, a diagnosis (eg, anemia, thrombocytopenia) should be recorded in the eCRF 
rather than the abnormal laboratory test result (eg, low hemoglobin, platelet count decreased). 
• Exacerbation of a chronic or intermittent pre-existing condition including either an increase in 
frequency and/or intensity of the condition, is to be reported as an AE. 
• New conditions detected or diagnosed after study treatment administration even though they may 
have been present before the start of the study. 
• Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction are to be reported as 
an AE. 
• Signs and/or symptoms from dosing errors of a study treatment (eg, overdose) or a concomitant 
medication are to be reported as an AE. 
• "Lack of efficacy," "disease progression," or "failure of expected pharmacological action" will not be 
reported as an AE or SAE.  Such instances will be captured in the efficacy assessments. 
• A condition that leads to a medical or surgical procedure (eg, endoscopy, appendectomy) will be 
reported as an AE if it occurs after obtaining informed consent.  If the condition is present before 
entering the study, then it should be captured as medical history. 
• Pre-existing diseases or conditions with expected fluctuations in signs or symptoms should be 
reported as an AE only if the investigator judges the fluctuation to have worsened more than 
expected during study participation. 


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9.2. 
Definition of Serious Adverse Event 
If an event is not an AE per the definition above, then it cannot be an SAE even if serious 
conditions are met (eg, hospitalization for signs/symptoms of the disease under study, death due 
to progression of disease). 
A Serious Adverse Event is defined as any untoward medical occurrence that, at any dose: 
a. Results in death 
b. Is life-threatening 
The term "life-threatening" in the definition of "serious" refers to an adverse drug experience that 
places the participant, in the opinion of the initial reporter, at immediate risk of death from the adverse 
experience as it occurs.  This does not include an adverse drug experience that, had it occurred in a 
more severe form, might have caused death. 
c. Requires inpatient hospitalization or prolongation of existing hospitalization 
In general, hospitalization signifies that the participant has been detained (involving at least an 
overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have 
been appropriate in the physician's office or outpatient setting.  Complications that occur during 
hospitalization are AEs.  If a complication prolongs hospitalization or fulfills any other serious criteria, 
the event is serious.  When in doubt as to whether hospitalization occurred or was necessary, the AE 
should be considered serious. 
Hospitalization for elective treatment or planned surgery (eg, stent replacement, hip surgery) is not 
considered an SAE. 
Hospitalization for medical interventions in which no unfavorable medical occurrence occurred 
(ie, elective procedures or routine medical visits) are not considered SAEs. 
d. Results in persistent or significant disability/incapacity 
• The term "disability" means a substantial disruption of a person's ability to conduct normal life 
functions.  This definition is not intended to include experiences of relatively minor medical 
significance, such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and accidental 
trauma (eg, sprained ankle), that may interfere with or prevent everyday life functions but do not 
constitute a substantial disruption. 
e. Is a congenital anomaly/birth defect 
f. Other situations (Important Medical Event) 
An important medical event is an event that may not result in death, be immediately life-threatening, or 
require hospitalization but may be considered serious when, based on appropriate medical judgment, 
the event may jeopardize the participant and may require medical or surgical intervention to prevent 
one of the outcomes listed in the above definition. Examples of such events include new invasive or 
malignant cancers (excluding the disease[s] under study, FL or MZL); intensive treatment in an 
emergency department or at home for allergic bronchospasm, blood dyscrasias, or convulsions that do 
not result in hospitalization; development of drug dependency or drug abuse; or suspected transmission 
of an infectious agent via a medicinal product.  Secondary malignancies should always be considered 
SAEs. 
An event that may lead to disability is also considered an important medical event.  It includes a case 
that is exposed to a risk of dysfunction to an extent that interferes with daily life when the adverse drug 
reaction occurs.  It does not include an adverse drug reaction that, had the reaction been more severe, 
may have caused disability. 


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9.3. 
Recording and Follow-Up of Adverse Events and/or Serious Adverse 
Events 
Adverse Event and Serious Adverse Event Recording 
• An AE/SAE that begins or worsens after informed consent is signed should be recorded on the 
Adverse Event Form in the eCRF.  AEs/SAEs should be reported for enrolled participants, but only 
SAEs need to be reported for screen failure participants.  For enrolled participants, conditions that 
were present at the time informed consent was given should be recorded on the Medical History 
eCRF.  For detailed information refer to the eCRF guidelines. 
• When an AE/SAE occurs, it is the responsibility of the investigator to review all documentation (eg, 
hospital progress notes, laboratory reports, and diagnostics reports) related to the event. 
• The investigator (or delegate) will then record all relevant AE/SAE information in the eCRF. 
• It is not acceptable for the investigator to send photocopies of the participant's medical records in 
lieu of completing the Adverse Event Form in the eCRF. 
• There may be rare instances when copies of medical records for certain cases are requested.  In this 
case, all participant identifiers, with the exception of the participant number, will be redacted by the 
site staff on the copies of the medical records before submission.  These records can be submitted to 
Incyte Pharmacovigilance by email/fax per the contact information listed in the SAE completing 
guidelines. 
• The investigator will attempt to establish a diagnosis of the event based on signs, symptoms, and/or 
other clinical information.  Whenever possible, the diagnosis (not the individual signs/symptoms) 
will be documented as the AE/SAE.  When a clear diagnosis cannot be identified, each sign or 
symptom should be reported as a separate AE/SAE. 
To the extent possible, each AE/SAE should be evaluated to determine the following: 
• The severity grade (CTCAE v5.0 Grade 1 to 5).  See below for further instructions on the assessment 
of intensity. 
• Whether there is at least a reasonable possibility that the AE is related to the study treatment:  
suspected (yes) or not suspected (no).  See below for further instructions on the assessment of 
causality. 
• The start and end dates, unless unresolved at final safety follow-up (30 to 35 days after the EOT 
visit). 
• The action taken with regard to study treatment as a result of the AE/SAE(s). 
• The event outcome (eg, not recovered/not resolved, recovered/resolved, recovering/resolving, 
recovered/resolved with sequelae, fatal, unknown). 
• The seriousness, as per the SAE definition provided in Section 9.2. 
• The action taken with regard to the event.  Note:  If an AE is treated with a concomitant medication 
or nondrug therapy, this action should be recorded on Adverse Event Form and the treatment should 
be specified on the appropriate eCRF (eg, Prior/Concomitant Medications, Procedures and Non-Drug 
Therapy). 


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Assessment of Intensity 
The severity of AEs will be assessed using CTCAE v5.0 Grades 1 through 5.  If an event is not 
classified by CTCAE, the severity of the AE will be graded according to the scale below to estimate the 
grade of severity: 
The investigator will make an assessment of intensity for each AE and SAE reported during the study 
and assign it to 1 of the following categories: 
• Grade 1:  Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment 
not indicated. 
• Grade 2:  Moderate; minimal, local, or noninvasive treatment indicated; limiting age appropriate 
activities of daily living. 
• Grade 3:  Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. 
• Grade 4:  Life-threatening consequences; urgent treatment indicated. 
• Grade 5:  Fatal. 
Assessment of Causality 
• The investigator is obligated to assess the relationship between study treatment and each occurrence 
of each AE/SAE.  If appropriate, the relationship to the combination may be assessed as well. 
• A "reasonable possibility" of a relationship conveys that there are facts, evidence, and/or arguments 
to suggest a causal relationship, rather than that a relationship cannot be ruled out. 
• The investigator will use clinical judgment to determine the relationship. 
• The investigator will also consult the RSI in the IB and/or Product Information, for marketed 
products, in their assessment. 
• Alternative causes, such as underlying disease(s), concomitant therapy, and other risk factors, as well 
as the temporal relationship of the event to study treatment administration, will be considered and 
investigated. 
• For each AE/SAE, the investigator must document in the medical notes that they have reviewed the 
AE/SAE and has provided an assessment of causality. 
• With regard to assessing causality of SAEs: 
− There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report.  However, the causality assessment is one of the criteria 
used when determining regulatory reporting requirements.  Therefore, it is very important that 
the investigator always make an assessment of causality for every event before the initial 
transmission of the SAE. 
− The investigator may change their opinion of causality in light of follow-up information and send a 
follow-up SAE report with the updated causality assessment. 
Follow-Up of Adverse Events and Serious Adverse Events 
• The investigator is obligated to perform or arrange for the conduct of supplemental measurements 
and/or evaluations as medically indicated or as requested by the sponsor to elucidate the nature 
and/or causality of the AE or SAE as fully as possible.  This may include additional laboratory tests 
or investigations, histopathological examinations, or consultation with other health care 
professionals. 


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• Once an AE is detected, it should be followed until the end of safety follow-up periods.  All SAEs 
and nonserious AESIs should be followed until resolution, stabilization, the event is otherwise 
explained, or the participant is lost to follow-up. Assessment should be made at each visit (or more 
frequently if necessary) of any changes in severity, the suspected relationship to the study drug, the 
interventions required to treat the event, and the outcome. 
• When the severity of an AE changes over time for a reporting period (eg, between visits), each 
change in severity will be reported as a separate AE. 
• Updated SAE information will be recorded in the originally completed eCRF and reported to Incyte 
Pharmacovigilance until resolution, stabilization, the event is otherwise explained, or the participant 
is lost to follow-up. 
• Any updated SAE data (including SAEs being downgraded to nonserious) will be submitted to the 
sponsor (or designee) within 24 hours of receipt of the information. 
9.4. 
Reporting of Serious Adverse Events 
Regardless of suspected causality (eg, relationship to study drugs, reference therapy, or study 
procedure), all SAEs occurring after the participant has signed the ICF through the last safety 
study visit, or until the participant starts a new anticancer therapy must be reported to the sponsor 
(or designee) immediately, without undue delay but not later than within 24 hours of obtaining 
knowledge of its occurrence unless otherwise specified by the Protocol.  The investigator will 
submit any updated SAE data to the sponsor (or designee) within 24 hours of it being available.  
This information must also be reported immediately to the head of the study site. 
Investigators are not obligated to actively seek SAE information after the safety follow-up visit 
or 30 to 35 days after the last dose of study treatment.  If the investigator learns of any SAE, 
including death, at any time during this period, and they consider the event to be reasonably 
related to the study treatment or study participation, then the investigator must notify the sponsor 
(or designee) within 24 hours of becoming aware of the event. 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts.  All SAEs and AEs of special interest (as defined in Section 9.5.1) 
will be followed until resolution, stabilization, the event is otherwise explained, or the participant 
is lost to follow-up (as defined in Section 7.3). 
Prompt notification by the investigator to the sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of a study 
treatment under clinical investigation are met. 
If the SAE is not documented in the RSI of the parsaclisib IB for the study treatment (new 
occurrence) and is thought to be related to the sponsor's study treatment, the sponsor or its 
designee may urgently require further information from the investigator for expedited reporting 
to health authorities.  The sponsor or its designee may need to issue an Investigator Notification 
to inform all investigators involved in any study with the same drug that this SAE has been 
reported.   The sponsor will report suspected expected deaths and life-threatening events to the 
PMDA as per local regulatory requirements. 
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study treatment under clinical investigation.  The 


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sponsor will comply with country-specific regulatory requirements relating to safety reporting to 
the regulatory authority, IRB/IEC, and investigators. 
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and sponsor policy and forwarded to investigators as necessary. 
An investigator who receives an investigator safety report describing a SAE or other specific 
safety information (eg, summary or listing of SAEs) from the sponsor will review and then file it 
along with the IB and will notify the IRB/IEC, if appropriate according to local requirements. 
Serious Adverse Event Reporting 
• Information about all SAEs is collected and recorded on the Adverse Event Form in the eCRF. 
• The investigator must report within 24 hours of learning of its occurrence any SAEs via the EDC 
system (primary method) or by completing the Serious Adverse Event Report Form in English (only 
if EDC system is not available.  The contact information for Incyte Pharmacovigilance by email/fax 
is listed in the Incyte Reference Guide for Completing the Serious Adverse Event Report Form). 
• In circumstances where the EDC system is not accessible for reporting SAE information (initial 
and/or follow-up SAE information) to the sponsor within 24 hours, refer to the Incyte Reference 
Guide for Completing the Serious Adverse Report Form.  Once the EDC system is functional, the 
SAE report should be retrospectively added to the EDC system and follow-up should be completed 
through the EDC.  The original copy of the Serious Adverse Event Report Form and the email or 
facsimile confirmation sheet must be kept at the study site (refer to the Incyte Reference Guide for 
Completing the Serious Adverse Report Form for details and for the email address or fax number). 
• Follow-up information is also recorded in the eCRF and transmitted to Incyte  Pharmacovigilance via 
the EDC system.  The follow-up report should include information that was not provided previously, 
such as the outcome of the event, treatment provided, action taken with study drug because of the 
SAE (eg, dose reduced, interrupted, or discontinued), or participant disposition (eg, continued or 
withdrew from study participation).  Each recurrence, complication, or progression of the original 
event should be reported as follow-up to that event, regardless of when it occurs. 
9.5. 
Events of Clinical Interest 
9.5.1. 
Adverse Events of Special Interest 
Specific AEs, or groups of AEs, will be followed as part of standard safety monitoring activities. 
• ALT ≥ 5 × ULN 
• AST ≥ 5 × ULN 
• Colitis 
• Diarrhea ≥ Grade 2  
• Rash ≥ Grade 2 
• Intestinal perforation 
• Pneumonitis 
• Pneumocystis jirovecii infection 
• CMV infection 


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• Herpes simplex virus infection 
• Varicella zoster virus infection 
• Exfoliative dermatitis 
9.6. 
Emergency Unblinding of Treatment Assignment 
Not applicable. 
9.7. 
Pregnancy 
Pregnancy, in and of itself, is not regarded as an AE unless there is suspicion that study drug may 
have interfered with the effectiveness of a contraceptive medication or method.  When a 
pregnancy has been confirmed in a participant during maternal or paternal exposure to study 
drug, the following procedures should be followed in order to ensure safety: 
• The study drug must be discontinued immediately (female participants only; see 
Section 6.5.4 for the maximum permitted duration of study drug interruption). 
• The investigator must complete and submit the Incyte Clinical Trial Pregnancy Form 
to the sponsor or its designee within 24 hours of learning of the pregnancy. 
Data on fetal outcome are collected for regulatory reporting and drug safety evaluation.  
Follow-up should be conducted for each pregnancy to determine outcome, including spontaneous 
or voluntary termination, details of the birth, and the presence or absence of any birth defects, 
congenital abnormalities, or maternal and/or newborn complications, by following until the first 
well-baby visit.  Pregnancy should be recorded on a Clinical Trial Pregnancy Form and reported 
by the investigator to the sponsor or its designee.  Pregnancy follow-up information should be 
recorded on the same form and should include an assessment of the possible causal relationship 
to the sponsor's study drug to any pregnancy outcome, as well as follow-up to the first well-baby 
visit or the duration specified in local regulations, whichever is later.  Refer to the Incyte 
Reference Guide for Completing the Clinical Trial Pregnancy Form. 
Any SAE occurring during pregnancy of a study participant must be recorded on the 
Serious Adverse Event Report Form and submitted to the sponsor or designee. 
Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, or ectopic pregnancy) are considered SAEs (if occurring in the study participant) and 
must be reported as described in Section 9.4.  If an abnormal pregnancy outcome is reported in a 
study participant's partner, the event should be reported to the sponsor on the Clinical Trial 
Pregnancy Form. 
9.8. 
Warnings and Precautions 
Infection with SARS-CoV-2, the coronavirus that causes COVID-19, is more frequent and 
severe in patients with hematologic dysfunction (Jee et al 2022).  The presence of hematologic 
malignancy, baseline neutropenia and lymphopenia, B-cell depletion, and other factors have been 
identified as risk factors for loss of humoral immunity to COVID-19, poor vaccine response, 
viral persistence, and severe disease (Lee et al 2022, Lyudovyk et al 2022, Shree et al 2022).  
Targeting B-cell function, proliferation, and survival with various therapies are current strategies 


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for improving the outcome of several hematologic malignancies.  Pi3Kδ inhibition with 
parsaclisib alone or in combination with other therapies, which may also suppress humoral 
immunity, has the potential to negatively impact SARS-CoV-2 infection risk, vaccine 
effectiveness, recovery from COVID-19, and disease severity (Cheson 2022).  Investigators and 
participants participating in trials of parsaclisib, alone or in combinations, need to be aware of 
these potential risks and consider the local standards of care and available therapies for disease 
prevention, vaccination, and infection management of COVID-19. 
Special warnings or precautions for the study drug, derived from safety information collected by 
the sponsor or its designee, are presented in the parsaclisib IB.  Additional safety information 
collected between IB updates will be communicated in the form of Investigator Notifications.  
Any important new safety information should be discussed with the participant during the study, 
as necessary.  If new significant risks are identified, they will be added to the ICF. 
9.9. 
Product Complaints 
The sponsor collects product complaints on study drugs and drug delivery systems used in 
clinical studies in order to ensure the safety of study participants, monitor quality, and facilitate 
process and product improvements. 
All product complaints associated with material packaged, labeled, and released by the sponsor 
or its designee will be reported to the sponsor.  Those complaints associated with unapproved 
medical devices will be reported to the sponsor with a Medical Device Defect Report Form, and 
the sponsor will report medical device defects to the PMDA as per local regulatory requirements.  
All product complaints associated with other study material will be reported directly to the 
respective manufacturer. 
The investigator or their designee is responsible for reporting a complete description of the 
product complaint via email or other written communication to the sponsor contact or respective 
manufacturer as noted in the packaging information.  Any AE associated with a product 
complaint should be recorded as described in Section 9.3. 
If the investigator is asked to return the product for investigation, they will return a copy of the 
product complaint communication with the product. 
Complaints associated with unapproved medical devices will be reported to the sponsor with a 
Medical Device Defect Report Form, and the sponsor will report medical device defects to the 
PMDA as per local regulatory requirements. 
9.10. 
Treatment of Overdose 
There has been no clinical experience with overdose of parsaclisib.  Treatment of overdose 
should consist of general supportive measures. 


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Subgroups will be formed based on the following participant characteristics and baseline 
variables: 
• Age:  ≤ 65 years, > 65 years 
• Gender:  male, female 
• Prior ASCT:  yes, no 
Subgroups may be further divided or combined based on emerging data.  The ORR and its 
95% CIs will be provided for each subgroup.  A forest plot will be created to summarize the 
variability in ORRs across subgroups. 
10.4.2. 
Analyses of Secondary Efficacy Endpoints 
Complete response rate is the percentage of participants with a CR as defined by revised 
response criteria for lymphomas, as determined by an IRC.  The CRR determined by the IRC and 
its 95% exact binomial CIs will be calculated. 
Duration of response is defined as the time from first documented evidence of CR or PR until 
disease progression or death due to any cause among participants who achieve an overall 
response, as determined by IRC.  For participants who have not progressed and are still alive at 
the time of the analysis, DOR will be censored on the day of last evaluable disease assessment.  
For participants who have discontinued study or have started other anti-lymphoma treatment, 
DOR will be censored on the day of last evaluable disease assessment documenting absence of 
PD before the discontinuation or the start of the new anti-lymphoma treatment.  Kaplan-Meier 
estimation of median DOR per IRC and its 95% CIs will be provided. 
Progression-free survival is defined as the time from the date of the first dose of study drug to the 
first documented disease progression as determined by IRC, or death due to any cause, 
whichever occurs first.  For participants who have not progressed and are still alive at the time of 
the analysis, PFS will be censored on the day of last evaluable disease assessment.  For 
participants who have discontinued study or have started other anti-lymphoma treatment, PFS 
will be censored on the day of last evaluable disease assessment documenting absence of PD 
before the discontinuation or the start of the new anti-lymphoma treatment.  For participants who 
have no baseline or no postbaseline disease assessment, PFS will be censored with duration of 
1 day.  Kaplan-Meier estimation of median PFS per IRC and its 95% CIs will be provided. 
Overall survival is defined as the time from the date of the first dose of study drug to death due 
to any cause.  For participants who are still alive at the time of the analysis, OS will be censored 
on the date the participant is last known to be alive.  The Kaplan-Meier estimation of median OS 
and its 95% CIs will be provided. 
For participants with measurable lesions at baseline, target lesion sizes will be measured by sum 
of the product of the diameters of all target lesions.  The best percentage change from baseline, 
defined as the largest decrease in target lesion sizes during the study, will be summarized 
descriptively.  Note that for participants who only have increases in target lesion sizes from 
baseline, the smallest increase will be considered as the best change from baseline.  Target 
lesions considered "too small to measure" will be assigned a default value of 5 mm × 5 mm for 
purposes of this analysis.  Likewise, target lesions identified as "not present" at postbaseline 
assessments will be assigned 0 mm for this analysis.  In the event that a target lesion is 


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11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
11.1. 
Investigator Responsibilities 
• The Protocol, Protocol Amendments, ICF, IB, and other relevant documents 
(eg, advertisements) must be submitted to an IRB/IEC by the investigator and 
reviewed and approved by the IRB/IEC and health authorities before the study is 
initiated. 
• The investigator is responsible for ensuring that the safety reports provided by the 
sponsor are reviewed and processed in accordance with regulatory requirements, the 
policies and procedures established by the IRB/IEC, and institutional requirements. 
• Any amendments to the Protocol will require approval from both health authorities 
and the IRB/IEC before implementation of changes made to the study design, except 
for changes necessary to eliminate an immediate hazard to study participants. 
• The investigator will be responsible for the following: 
− Providing written summaries of the status of the study to the IRB/IEC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/IEC. 
− Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures. 
− Providing oversight of the conduct of the study at the site and adherence to GCP, 
IRB/IEC requirements, institutional requirements, and applicable laws and 
country-specific regulations. 
• Adhering to the Protocol as described in this document and agreeing that changes to 
the Protocol procedures, with the exception of medical emergencies, must be 
discussed and approved, first, by the sponsor or its designee and, second, by the 
IRB/IEC.  Each investigator is responsible for enrolling participants who have met 
the specified eligibility criteria. 
• The record retainer (delegated by the head of the study site) will retain the 
J-GCP-defined essential documentation at this site until the regulatory approval of 
study drug(s)/treatment or at least 3 years after the discontinuation or completion of 
the study conduct, whichever is later.  If the sponsor requires retention of these 
documents for a longer period of time, the duration and method of retention will be 
decided upon through discussion between the sponsor and the study site.  It is the 
responsibility of the sponsor to inform the head of the study site as to when the 
documents no longer need to be retained. 


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• Retaining records in accordance with all local, national, and regulatory laws, but for a 
minimum period of at least 2 years after the last marketing application approval in an 
ICH region and until there are no pending or contemplated marketing applications in 
an ICH region, or if not approved, 2 years after the termination of the test article for 
investigation to ensure the availability of study documentation should it become 
necessary for the sponsor or a regulatory authority to review. 
− The investigator must not destroy any records associated with the study during the 
retention period without receiving approval from the sponsor.  The investigator 
must notify the sponsor or its designee in the event of accidental loss or 
destruction of any study records.  If the investigator leaves the institution where 
the study was conducted, the sponsor or its designee must be contacted to arrange 
alternative record storage options. 
• All eCRF data entered by the site (including audit trail), as well as computer 
hardware and software (for accessing the data), will be maintained or made available 
at the site in compliance with applicable record retention regulations.  The sponsor 
will retain the original eCRF data and audit trail. 
11.2. 
Data Management 
Data management will be performed in a validated EDC system.  The investigator will be 
provided with access to an EDC system so that an eCRF can be completed for each participant. 
The site will be provided with eCRF completion guidelines for instructions on data entry in the 
eCRF.  The study monitor will reference the Monitoring Plan in order to ensure that each issue 
identified is appropriately documented, reported, and resolved in a timely manner in accordance 
with the plan's requirements.  Other data outside the EDC system required in the study conduct 
of the Protocol, such as documents or results transmitted to the sponsor via a central laboratory 
or specialized technical vendors and as designated by the sponsor, will have their own data flow 
management plans, or study charters, 
 as applicable. 
The sponsor (or designee) will be responsible for the following: 
• Managing the integrity of the data and the quality of the conduct of the study, such as 
ensuring that study monitors perform ongoing source data verification to confirm that 
data entered into the eCRF by authorized site personnel are accurate, complete, and 
verifiable from source documents; that the safety and rights of participants are being 
protected; and that the study is being conducted in accordance with the currently 
approved Protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements. 
• Managing and reconciling the data generated and/or collected, including documents 
and results such as laboratory or imaging data analyzed centrally by a designated 
vendor of the sponsor. 


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The investigator will be responsible for the following: 
• Recording, or ensuring the recording of, all relevant data relating to the study in the 
eCRF. 
• Delivering, or ensuring the delivery of, all other results, documents, data, know-how, 
or formulas relating to the study to the sponsor or designee electronically and/or 
centrally (eg, laboratory data, imaging data, 
 photographs, diary data) 
or as otherwise specified in the Protocol. 
• Verifying that data entries are accurate and correct by physically or electronically 
signing the eCRF. 
• Maintaining accurate documentation (source data) that supports the information 
entered in the eCRF, sent to a central vendor designated by the sponsor, or as 
described in other study and data flow manuals. 
− Source documents provide evidence for the existence of the participant and 
substantiate the integrity of the data collected.  Source documents are filed and 
available at the investigator's site.  Examples of source documents are original 
documents, data, and records (eg, hospital records; electronic hospital records; 
clinical and office charts; laboratory notes; memoranda; participants' diaries or 
evaluation checklists; pharmacy dispensing records; recorded data from 
automated instruments; copies or transcriptions certified after verification as 
being accurate copies; microfiches; photographic negatives; microfilm or 
magnetic media; x-rays; participants' files; and e-records/records kept at the 
pharmacy, at the laboratories, and at medico-technical departments involved in 
the clinical trial). 
− Data entered in the eCRF that are transcribed from source documents must be 
consistent with the source documents or the discrepancies must be explained.  The 
investigator may need to request previous medical records or transfer records, 
depending on the study.  Current applicable medical records must be available. 
• May have responsibility for sending participants' data, either as unique samples, or 
copies, or photographs, to be evaluated centrally or analyzed centrally, or both, by a 
qualified vendor designated by the sponsor. 
• Sending participants' data, either as unique samples, copies, or photographs, to be 
evaluated centrally or analyzed centrally, or both, by a qualified vendor designated by 
the sponsor. 
− As required by privacy and data protection regulations and Incyte's privacy 
policies, if any photographs of participants are to be taken, the photographs must 
be limited to the area of the face or the body that is strictly necessary and the 
photographs should be masked (ie, identifying features such as eyes, mouth, scars, 
tattoos, or unique markings or features should be either obscured with a black bar 
or digitally pixelated so as to not permit the reidentification of the participants and 
preserve their confidentiality) by a specially designated photography vendor prior 
to sending the photographs to Incyte or any other third-party vendors for analysis 
or further processing. 


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• Permitting study-related monitoring, sponsor audits, IRB/IEC review, and regulatory 
inspections by providing direct access to source data and other relevant clinical study 
documents. 
− Monitoring:  Qualified representatives of the sponsor or its designee, study 
monitors, will monitor the study according to a predetermined plan.  The 
investigator must allow the study monitors to review any study materials and 
participant records at each monitoring visit. 
− Auditing:  Qualified representatives of the sponsor or its designee may audit the 
clinical study site and study data to evaluate compliance with the Protocol, 
applicable local clinical study regulations, and overall study conduct.  The 
investigator must allow the auditors to review original source records and study 
documentation for all participants. 
− Regulatory inspection:  Regulatory authorities may conduct an inspection of the 
study and the site at any time during the development of an investigational 
product.  The investigator and staff are expected to cooperate with the inspectors 
and allow access to all source documents supporting the eCRFs and other 
study-related documents.  The investigator must immediately notify the sponsor 
when contacted by any regulatory authority for the purposes of conducting an 
inspection. 
11.3. 
Data Quality Assurance 
The sponsor assumes accountability for actions delegated to other individuals (eg, contract 
research organizations).  The sponsor or designee is responsible for the data management of this 
study, including quality checking of the data.  Further, monitoring details describing strategy, 
including definition of study-critical data items and processes (eg, risk-based initiatives in 
operations and quality such as risk management and mitigation strategies and analytical 
risk-based monitoring), methods, responsibilities, and requirements, including handling of 
noncompliance issues, Protocol deviations, and monitoring techniques (eg, central, remote, or 
on-site monitoring) are provided in the Clinical Monitoring Plan. 
Quality tolerance limits will be predefined in the Incyte's SOPs and work instructions to identify 
systematic issues that can impact participants' safety, efficacy results and analysis, and/or 
reliability of study results.  These predefined parameters will be monitored during the study and 
can be adjusted during the study upon data review.  Important deviations from the quality 
tolerance limits and remedial actions taken, including reporting to IRBs/IECs and health 
authorities if applicable, will be summarized in the CSR. 
11.4. 
Data Privacy and Confidentiality of Study Records 
The investigator and the sponsor or its designee must adhere to applicable data protection laws 
and regulations.  The investigator and the sponsor or its designee are responsible for ensuring 
that personal information is handled in accordance with local data protection laws (including but 
not limited to HIPAA and GDPR) as applicable, and the sponsor operates comprehensive data 
privacy and data security programs that are applicable to this study.  Appropriate notice, or 
notice and consent (as may be required by each applicable jurisdiction), for collection, use, 


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disclosure, and/or transfer (if applicable) of personal information must be obtained in accordance 
with local data protection laws.  Appropriate data protection terms that comply with applicable 
laws will be included in relevant study agreements. 
To ensure confidentiality of records and protect personal data, participant names will not be 
supplied to the sponsor or its designee.  Only the participant number will be recorded in the 
eCRF; if the participant's name appears on any other document (eg, laboratory report), it must be 
obliterated on the copy of the document to be supplied to the sponsor or its designee.  Study 
findings stored on a computer will be stored in accordance with appropriate technical and 
organizational measures as required by local data protection laws. 
In the event of a data breach involving participant data, the sponsor or its designee will follow 
the sponsor's incident response procedures.  The precise definition of a data breach varies in 
accordance with applicable law but may generally be understood as a breach of security leading 
to the accidental or unlawful destruction, loss, alteration, unauthorized disclosure of, or access to, 
personal data.  In accordance with its incident response procedures, the sponsor will assess the 
breach to consider its notification and remediation obligations under applicable law. 
11.5. 
Financial Disclosure 
Before study initiation, all clinical investigators participating in clinical studies subject to FDA 
Regulation Title 21 CFR Part 54 – Financial Disclosure by Clinical Investigators (ie, "covered 
studies") are required to submit a completed Clinical Investigator Financial Disclosure Form that 
sufficiently details any financial interests and arrangements that apply.  For the purpose of this 
regulation, "clinical investigator" is defined as any investigator or subinvestigator who is directly 
involved in the treatment or evaluation of research participants, including the spouse and each 
dependent child of the clinical investigator or subinvestigator.  These requirements apply to both 
US and foreign clinical investigators conducting covered clinical studies. 
Any new clinical investigators added to the covered clinical study during its conduct must also 
submit a completed Clinical Investigator Financial Disclosure Form.  During a covered clinical 
study, any changes to the financial information previously reported by a clinical investigator 
must be reported to the sponsor or its designee.  At the conclusion of the covered clinical study, 
the clinical investigators will be reminded of their obligations.  In the event that the clinical 
investigator is not reminded, they nevertheless will remain obligated to report to the sponsor or 
its designee any changes to the financial information previously reported, as well as any changes 
in their financial information for a period of 1 year after completion of the covered clinical study. 
11.6. 
Publication Policy 
By signing the study Protocol, the investigator and their institution agree that the results of the 
study may be used by the sponsor, Incyte Corporation/Incyte Biosciences Japan GK (Incyte), for 
the purposes of national and international registration, publication, and information for medical 
and pharmaceutical professionals.  Study results will be published in accordance with applicable 
local and national regulations.  If necessary, the authorities will be notified of the investigator's 
name, address, qualifications, and extent of involvement.  The terms regarding the publication of 
study results are contained in the agreement signed with the sponsor or its designee.  A signed 
agreement will be retained by the sponsor or its designee. 


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12. 
REFERENCES 
Aliqopa (copanlisib) [prescribing information]. Bayer HealthCare Pharmaceuticals Inc.; 
November 2020. 
Amit O, Mannino F, Stone AM, et al. Blinded independent central review of progression in 
cancer clinical trials: results from a meta-analysis. Eur J Cancer 2011;47:1772-1778. 
Barekman CL, Aguilera NS, Abbondanzo SL. Low-grade B-cell lymphoma with coexpression of 
both CD5 and CD10. A report of 3 cases. Arch Pathol Lab Med 2001;125:951-953. 
Cantley LC. The phosphoinositide 3-kinase pathway. Science 2002;296:1655-1657. 
Casulo C, Byrtek M, Dawson KL, et al. Early relapse of follicular lymphoma after rituximab 
plus cyclophosphamide, doxorubicin, vincristine, and prednisone defines patients at high risk for 
death: an analysis from the National LymphoCare Study. J Clin Oncol 2015;33:2516-2522. 
Cheson BD. Death and clinical trials in the plague years. Accessed July 21, 2022. 
https://ascopost.com/issues/july-10-2022/death-and-clinical-trials-in-the-plague-years. 
Cheson BD, Fisher RI, Barrington SF, et al. Recommendations for initial evaluation, staging, and 
response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin 
Oncol 2014;32:3059-3068. 
Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. 
J Clin Oncol 2007;25:579-586. 
Clinical Trial Facilitation and Coordination Group. Recommendations related to contraception 
and pregnancy testing in clinical trials. 2014. 
Copiktra (duvelisib) [prescribing information]. Verastem, Inc; July 2019. 
Coutré S, Barrientos JC, Brown JR, et al. Management of adverse events associated with 
idelalisib treatment: expert panel opinion. Leuk Lymphoma 2015;56:2779-2786. 
Dreyling M, Santoro A, Mollica L, et al. Phosphatidylinositol 3-kinase inhibition by copanlisib 
in relapsed or refractory indolent lymphoma. J Clin Oncol 2017;35:3898-3950. 
Flinn IW, Miller CB, Ardeshna KM, et al. DYNAMO: a Phase II study of duvelisib (IPI-145) in 
patients with refractory indolent non-Hodgkin lymphoma. J Clin Oncol 2019;37:912-922. 
Forero-Torres A, Ramchandren R, Yacoub A, et al. Parsaclisib, a potent and highly selective 
PI3Kd inhibitor, in patients with relapsed or refractory B-cell malignancies. Blood 
2019;133:1742-1752. 
Izutsu K. JSH practical guidelines for hematological malignancies, 2018: II. Lymphoma-1. 
Follicular lymphoma (FL). Int J Hematol 2019;110:11-19. 
Jee J, Foote MB, Lumish M, et al. Chemotherapy and COVID-19 outcomes in patients with 
cancer. J Clin Oncol 2022;38:3538-3546. 
Kahl BS, Yang DT. Follicular lymphoma: evolving therapeutic strategies. Blood 
2016;127:2055-2063. 
Lee CY, Shah MK, Hoyos D, et al. Prolonged SARS-CoV-2 infection in patients with lymphoid 
malignancies. Cancer Discov 2022;12:62-73. 


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Lyudovyk O, Kim JY, Qualls D, et al. Impaired humoral immunity is associated with prolonged 
COVID-19 despite robust CD8 T cell responses. Cancer Cell 2022;40:738-753. 
National Cancer Institute. Common Terminology Criteria for Adverse Events Version 5.0. 2017. 
National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: B-Cell 
Lymphomas Version 1.2020. 
National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Prevention 
and Treatment of Cancer-Related Infections Version 1.2020. 
Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern 
Cooperative Oncology Group. Am J Clin Oncol 1982;5:649-655. 
Parsaclisib Investigator's Brochure (IB). Wilmington, DE: Incyte Corporation. 
Pastore A, Jurinovic V, Kridel R, et al. Integration of gene mutations in risk prognostication for 
patients receiving first-line immunochemotherapy for follicular lymphoma: a retrospective 
analysis of a prospective clinical trial and validation in a population-based registry. Lancet Oncol 
2015;16:1111-1122. 
Phillips TJ, Ramchandren R, Wertheim MS, et al. An ongoing open-label phase 1/2 study of 
INCB050465, a selective PI3Kδ inhibitor, in patients with previously treated B-cell 
malignancies. Blood 2016;128:4195. 
Shankland KR, Armitage JO, Hancock BW. Non-Hodgkin lymphoma. Lancet 
2012;380:848-857. 
Shree T, Shankar V, Lohmeyer JJK, et al. CD20-targeted therapy ablates de novo antibody 
response to vaccination but spares preestablished immunity. Blood Cancer Discov 
2022;3:95- 102. 
Solal-Céligny P, Roy P, Colombat P, et al. Follicular lymphoma international prognostic index 
Blood 2004;104:1258-1265. 
Swerdlow SH, Campo E, Pileri SA, et al. The 2016 revision of the World Health Organization 
classification of lymphoid neoplasms. Blood 2016;127:2375-2390. 
Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. 
CA Cancer J Clin 2015;65:87-108. 


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APPENDIX A. INFORMATION REGARDING EFFECTIVENESS OF 
CONTRACEPTIVE METHODS 
For male participants in the study: 
Male participants should use a condom from screening through 93 days after the end of systemic 
exposure.  If the male participant has a partner that is of child-bearing potential, the partner should also 
use contraception through 93 days after the end of relevant systemic exposure.  In addition, male 
participants must refrain from donating sperm from screening through 93 days after the end of relevant 
systemic exposure.  Males who have had a vasectomy qualify as having met the requirement for a 
highly effective birth control method. 
For female participants in the study: 
The following methods that can achieve a failure rate of less than 1% per year when used consistently 
and correctly are considered as highly effective birth control methods: 
•
Combined (estrogen and progestogen containing) hormonal contraception associated with
inhibition of ovulationa
−
oral
•
Progestogen-only hormonal contraception associated with inhibition of ovulationa
−
oral
−
injectable
−
implantableb
•
Intrauterine deviceb
•
Intrauterine hormone-releasing systemb
•
Bilateral tubal occlusionb
•
Vasectomized partnerbc
Acceptable birth control methods that result in a failure rate of more than 1% per year include: 
•
Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary
mode of action
•
Male or female condom with or without spermicided
•
Cap, diaphragm, or sponge with spermicided
•
Tubal ligation
a Hormonal contraception may be susceptible to interaction with the investigational medicinal product, which may 
reduce the efficacy of the contraception method. 
b Contraception methods that in the context of this guidance are considered to have low user dependency. 
c Vasectomized partner is a highly effective method of avoiding pregnancy provided that partner is the sole sexual 
partner of the woman of childbearing potential study participant and that the vasectomized partner has received 
medical assessment of the surgical success. 
d A combination of male condom with either cap, diaphragm, or sponge with spermicide (double barrier methods) 
are also considered acceptable, but not highly effective, birth control methods. 
Source:  Clinical Trial Facilitation and Coordination Group 2014. 


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APPENDIX B. CYP3A INHIBITORS AND INDUCERS 
CYP3A inhibitors or inducers may alter parsaclisib concentration.  These include but are not 
limited to the drugs listed below. 
CYP3A Inhibitors 
Inhibitor 
Therapeutic Class 
Potent CYP3A Inhibitors  
VIEKIRA PAK 
Antivirals 
indinavir /RIT 
Protease Inhibitors 
tipranavir/RIT 
Protease Inhibitors 
ritonavir 
Protease Inhibitors 
cobicistat (GS-9350) 
None 
ketoconazole 
Antifungals 
indinavir 
Protease Inhibitors 
troleandomycin 
Antibiotics 
telaprevir 
Antivirals 
danoprevir / RIT 
Antivirals 
elvitegravir / RIT 
Treatments of AIDS 
saquinavir / RIT 
Protease Inhibitors 
lopinavir / RIT 
Protease Inhibitors 
itraconazole 
Antifungals 
voriconazole 
Antifungals 
mibefradil 
Calcium Channel Blockers 
LCL161 
Cancer Treatments 
clarithromycin 
Antibiotics 
posaconazole 
Antifungals 
telithromycin 
Antibiotics 
grapefruit juice DS 
Food Products 
conivaptan 
Diuretics 
nefazodone 
Antidepressants 
nelfinavir 
Protease Inhibitors 
saquinavir 
Protease Inhibitors 
ribociclib 
Kinase Inhibitors 
idelalisib 
Kinase Inhibitors 
boceprevir 
Antivirals 


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Moderate CYP3A Inhibitors  
erythromycin 
Antibiotics 
fluconazole 
Antifungals 
atazanavir / RIT 
Protease Inhibitors 
darunavir 
Protease Inhibitors 
diltiazem 
Calcium Channel Blockers 
darunavir / RIT 
Protease Inhibitors 
dronedarone 
Antiarrhythmics 
crizotinib 
Kinase Inhibitors 
atazanavir 
Protease Inhibitors 
letermovir 
Antivirals 
GSK2647544 
Alzheimer's Disease & Dementia Treatments 
aprepitant 
Antiemetics 
casopitant 
Antiemetics  
amprenavir 
Protease Inhibitors 
faldaprevir 
Antivirals 
imatinib 
Antineoplastic Agents 
verapamil 
Calcium Channel Blockers 
netupitant 
Antiemetics 
nilotinib 
Kinase Inhibitors 
grapefruit juice 
Food Products 
tofisopam 
Benzodiazepines 
cyclosporine 
Immunosuppressants 
ACT-178882 
Renin Inhibitors 
ciprofloxacin 
Antibiotics 
Magnolia vine (Schisandra sphenanthera) 
Herbal Medications 
isavuconazole 
Antifungals 
cimetidine 
H-2 Receptor Antagonists 
FK1706 
Central Nervous System Agents 


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Weak CYP3A Inhibitors 
tabimorelin 
Hormone Replacement 
amlodipine 
Calcium Channel Blockers 
ranolazine 
Cardiovascular Drugs 
breviscapine 
Herbal Medications 
lomitapide 
Other Antilipemics 
fosaprepitant (IV) 
Antiemetics 
Seville orange (Citrus aurantium) juice 
Food Products 
amiodarone 
Antiarrhythmics 
diosmin 
Herbal Medications 
chlorzoxazone 
Muscle Relaxants 
M100240 
Antihypertensive Agents 
fluvoxamine 
Antidepressants 
ranitidine 
H-2 Receptor Antagonists 
goldenseal 
Herbal Medications  
clotrimazole 
Antifungals 
tacrolimus 
Immunosuppressants 
palbociclib 
Kinase Inhibitors 
cilostazol 
Antiplatelets 
ticagrelor 
Antiplatelets 
peppermint oil 
Food Products 
ivacaftor 
Cystic fibrosis treatments 
GSK2248761 
Transcriptase Inhibitors 
Guan Mai Ning 
Herbal Medications 
osilodrostat 
Adrenal Steroidogenesis Inhibitors 
AZD2327 
Depression Treatments 
piperine 
Food Products 
resveratrol 
Food Products 
roxithromycin 
Antibiotics 
suvorexant 
Hypnotics - Sedatives 
propiverine 
Anticholinergics 
isoniazid 
Antibiotics 
berberine 
Herbal Medications 
oral contraceptives 
Oral contraceptives 
delavirdine 
NNRTIs 
daclatasvir 
Antivirals 
simeprevir 
Protease Inhibitors 
atorvastatin 
HMG CoA Reductase Inhibitors (Statins) 


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tolvaptan 
Vasopressin Antagonists 
almorexant 
Hypnotics - Sedatives 
GSK1292263 
Other Antilipemics 
evacetrapid 
CETP inhibitors 
linagliptin 
Dipeptidyl Peptidase 4 Inhibitors 
grazoprevir (ingredient of Zepatier) 
Antivirals 
lacidipine 
Calcium Channel Blockers 
cranberry juice 
Food Products 
pazopanib 
Kinase Inhibitors 
fostamatinib 
Other 
everolimus 
Immunosuppressants 
blueberry juice 
Food Products 
flibanserin 
Central Nervous System Agents 
lapatinib 
Kinase Inhibitors 
brodalumab 
Immunomodulators Biologics 
AMD070 
Fusion Inhibitors  
alprazolam 
Benzodiazepines 
Tong Xin Luo 
Herbal Medications 
glecaprevir and pibrentasvir 
Antivirals 
bicalutamide 
Antiandrogens 
sitaxentan 
Endothelin Receptor Antagonists 
azithromycin 
Antibiotics 
obeticholic acid 
Miscellaneous Agents 
ginkgo 
Herbal Medications 
teriflunomide 
Other Immunomodulators 


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CYP3A Inducers 
Inducers 
Therapeutic class 
Potent Inducers  
rifampin 
Antibiotics  
mitotane 
Other Antineoplastics  
avasimibe 
Other Antilipemics  
rifapentine 
Antibiotics  
apalutamide 
Antiandrogens  
phenytoin 
Anticonvulsants  
carbamazepine 
Anticonvulsants  
enzalutamide 
Antiandrogens  
St John's Wort extract 
Herbal Medications  
lumacaftor 
Cystic Fibrosis Treatments 
rifabutin 
Antibiotics  
phenobarbital 
Anticonvulsants  
Moderate Inducers  
ritonavir and St Johns wort 
None  
semagacestat 
Alzheimer's Treatments 
efavirenz 
NNRTIs 
tipranavir and ritonavir 
Protease Inhibitors  
dabrafenib 
Kinase Inhibitors  
lesinurad 
Antigout and Uricosuric Agents 
bosentan 
Endothelin Receptor Antagonists  
genistein 
Food Products  
thioridazine 
Antipsychotics  
nafcillin 
Antibiotics  
talviraline 
NNRTIs 
lopinavir 
Protease Inhibitors 
modafinil 
Psychostimulants 
PF-06282999 
Myeloperoxidase Inactivators 
etravirine 
NNRTIs 
lersivirine 
NNRTIs 
telotristat ethyl 
Antidiarrheals 


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Weak Inducers  
eslicarbazepine 
Anticonvulsants  
telaprevir 
Antivirals  
daclatasvir and asunaprevir and beclabuvir 
Antivirals  
amenamevir 
Antivirals  
garlic 
Food Products  
bexarotene 
Other Antineoplastics 
sarilumab 
Immunomodulators Biologics 
artesunate and mefloquine 
Antimalarials 
amprenavir (fosamprenavir) 
Protease Inhibitors  
raltegravir 
HIV-Integrase Strand Transfer Inhibitors  
vemurafenib 
Kinase Inhibitors  
troglitazone 
Thiazolidinediones  
dicloxacillin 
Antibiotics  
sorafenib 
Kinase Inhibitors  
rufinamide 
Anticonvulsants  
sirukumab 
Immunomodulators Biologics 
pleconaril 
Antivirals  
ginseng 
Herbal Medications  
boceprevir 
Antivirals  
sulfinpyrazone 
Antigout and Uricosuric Agents 
ginkgo 
Herbal Medications  
vinblastine 
Vinca Alkaloids  
nevirapine 
NNRTIs 
armodafinil (R-modafinil) 
Psychostimulants  
ticagrelor 
Anticoagulants and Antiplatelets  
LCL161 
Cancer Treatments 
vicriviroc and ritonavir 
Treatments of AIDS 
ritonavir 
Protease Inhibitors  
prednisone 
Corticosteroids  
oxcarbazepine 
Anticonvulsants  
danshen 
Herbal Medications  
clobazam 
Benzodiazepines  
echinacea 
Herbal Medications  
ticlopidine 
Anticoagulants and Antiplatelets  
isavuconazole 
Antifungals  


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brivaracetam 
Anticonvulsants  
Stribild 
Treatments of AIDS 
pioglitazone 
Thiazolidinediones  
VIEKIRA PAK 
Antivirals  
dexamethasone 
Corticosteroids  
terbinafine 
Antifungals  
quercetin 
Food Products 
glycyrrhizin 
Herbal Medications  
aprepitant 
Neurokinin-1 Receptor Antagonists 
pretomanib (PA-824) 
Antibiotics  
safinamide 
MAO-B Inhibitors 
oritavancin 
Antibiotics  
AZD 7325 
Anxiolytics 
methylprednisolone 
Corticosteroids  
topiramate 
Anticonvulsants  
 


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APPENDIX C. EASTERN COOPERATIVE ONCOLOGY GROUP 
PERFORMANCE STATUS 
Eastern Cooperative Oncology Group Performance Scores 
Grade 
Performance Status 
0 
Fully active, able to carry on all predisease performance without restriction. 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out work of a 
light or sedentary nature, eg, light house work, office work. 
2 
Ambulatory and capable of all self-care but unable to carry out any work activities.  Up 
and about more than 50% of waking hours. 
3 
Capable of only limited self-care, confined to bed or chair more than 50% of waking 
hours. 
4 
Completely disabled.  Cannot carry on any self-care.  Totally confined to bed or chair. 
5 
Dead. 
Source:  Oken et al 1982. 


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APPENDIX D. LUGANO CLASSIFICATION FOR RESPONSE 
ASSESSMENT (CT-BASED ONLY) 
Site 
CT-Based Response 
 
Complete radiologic response 
(all of the following) 
Lymph nodes and 
extralymphatic sites  
Target nodes/nodal masses must regress to ≤ 1.5 cm in LDi. 
Nonmeasured lesion  
Absent. 
Organ enlargement  
Regress to normal. 
New lesions  
None. 
Bone marrow  
Normal by morphology; if indeterminate, immunohistochemistry negative. 
 
Partial remission (all of the following) 
Lymph nodes and 
extralymphatic sites  
• ≥ 50% decrease in SPD of up to 6 target measurable nodes and extranodal sites. 
• When a lesion is too small to measure on CT, assign 5 mm × 5 mm as the default. 
• When no longer visible, 0 × 0 mm. 
For a node > 5 mm × 5 mm but smaller than normal, use actual measurement. 
Nonmeasured lesions  
Absent/regressed, but no increase. 
Organ enlargement  
Spleen must have regressed by > 50% in length beyond normal. 
New lesions  
None. 
Bone marrow 
Not applicable. 
 
Stable disease 
Target nodes/nodal 
masses, extranodal 
lesions  
< 50% decrease from baseline in SPD of up to 6 dominant, measurable nodes and 
extranodal sites; no criteria for PD are met. 
Nonmeasured lesions  
No increase consistent with progression. 
Organ enlargement  
No increase consistent with progression. 
New lesions  
None. 
Bone marrow  
Not applicable. 


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Site 
CT-Based Response 
 
Progressive disease 
(requires at least 1 of the following) 
Individual target 
nodes/nodal lesions  
PPD progression:  
• An individual node/lesion must be abnormal with all of the following: 
- LDi > 1.5 cm. 
- Increase by ≥ 50% from PPD nadir. 
- Increase in LDi or SDi from nadir: 
o 0.5 cm for lesions ≤ 2 cm. 
o 1.0 cm for lesions > 2 cm. 
• In the setting of splenomegaly, the splenic length must increase by > 50% of the 
extent of its prior increase beyond baseline (eg, a 15 cm spleen must increase to 
> 16 cm).  If no prior splenomegaly, must increase by at least 2 cm from baseline. 
• New or recurrent splenomegaly. 
• New or clear progression of pre-existing nonmeasured lesions. 
• Regrowth of any previously resolved lesions. 
• A new node > 1.5 cm in any axis. 
• A new extranodal site > 1.0 cm in any axis; if < 1.0 cm in any axis, its presence 
must be unequivocal and must be attributable to lymphoma. 
• Assessable disease of any size unequivocally attributable to lymphoma. 
• New or recurrent involvement of the bone marrow. 
CT = computed tomography; EOT = end of treatment; LDi = longest transverse diameter of lesion; MRI = magnetic resonance 
imaging; PPD = cross-product of the longest transverse diameter and perpendicular diameter; SDi = shortest axis perpendicular 
to the longest transverse diameter; SPD = sum of the product of the perpendicular diameters for multiple lesions. 


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APPENDIX E. FOLLICULAR LYMPHOMA INERNATIONAL 
PROGNOSTIC INDEX 
Scoring System 
Parameter 
Value 
Point Score 
Age 
> 60 years of age 
1 
Ann Arbor stage 
Stage III or IV 
1 
Hemoglobin level 
< 120 g/L (12.0 g/dL or 6.37 mmol/L) 
1 
Serum LDH 
> ULN 
1 
Number of Nodal Sites 
> 5 
1 
Risk Group by FLIPI Total Point Score 
Risk Group 
Total Point Score 
Low 
≤ 1 
Intermediate 
2 
High 
≥ 3 
 


Incyte Biosciences Japan GK 
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APPENDIX F. PROTOCOL AMENDMENT SUMMARY OF CHANGES 
DOCUMENT HISTORY 
Document 
Date 
Amendment 1 (Version 2): 
25 JUN 2020 
Amendment 2 (Version 3): 
19 MAY 2021 
Amendment 3 (Version 4): 
07 OCT 2022 
Amendment 4 (Version 5): 
24 JAN 2023 
Amendment 4 (24 JAN 2023) 
Overall Rationale for the Amendment: 
The primary purpose to this amendment is to enable the study to close ahead of the original plan 
by updating the minimum study participation period.  
1. Section 1, Protocol Summary (Table 2:  Key Study Design Elements) 
Description of change:  Changed the estimated duration of study participation from 
25 months to 16 months.  
Rationale for change:  Consistency with the change in the minimum study participation 
period. 
 
 
 
  
 
 
3. Section 4.2, Overall Study Duration; Section 6.7, Treatment After the End of the 
Study; Section 8.9, End of Study 
Description of change:  Changed the minimum study participation period from 
24 months to 12 months to trigger the end of the study.  
Rationale for change:  Based on the time to response data from a non-Japanese study, 
the minimum observation period required for evaluation of the primary endpoint (ORR) 
was updated. 
4. Section 8.2.1, Computed Tomography Scan or Magnetic Resonance Imaging 
Description of change:  Added text that no further imaging is required once all 
participants complete at least 12 months of study participation. 
Rationale for change:  To clarify the required period for CT/MRI. 
5. Incorporation of administrative changes. Other regulatory guidance and administrative 
changes have been incorporated throughout the Protocol and are noted in the redline 
version of the amendment. 


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Amendment 3 (07 OCT 2022) 
Overall Rationale for the Amendment: 
The primary purpose of this amendment is to describe risks associated with COVID-19. 
1. Section 2.3, Benefit/Risk Assessment 
Description of change:  Added language to address possible risks of serious infection 
events. 
Rationale for change:  Clarify the possible risk of infection. 
2. Section 9.8, Warnings and Precautions  
Description of change:  Added new section describing risks associated with COVID-19 
with regards to participants with hematologic disorders and treatment with parsaclisib. 
Rationale for change:  Provided for informational purposes. 
3. Incorporation of administrative changes.  Other regulatory guidance and 
administrative changes have been incorporated throughout the Protocol and are noted in 
the redline version of the amendment. 


Incyte Biosciences Japan GK 
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Amendment 2 (19 MAY 2021) 
Overall Rationale for the Amendment: 
The primary purpose of this amendment is to change inclusion criteria for the purpose of 
stimulating enrollment and to align with Japan GCP requirement(s). 
1. Section 1, Protocol Summary (Table 3:  Schedule of Activities) 
Description of change:  Added "after EOT" to survival follow-up and the test item of 
FDG-PET to the list of procedures. 
Rationale for change:  Clarified the timing of survival follow-up and added FDG-PET 
due to the modification of inclusion criteria. 
2. Section 1, Protocol Summary (Table 4:  Schedule of Laboratory Assessments) 
Description of change:  Added explanation that a tumor biopsy is not mandatory for 
participants who submit earlier archived lymph nodes or tissue biopsies to notes for 
tumor biopsy. 
Rationale for change: Due to the modification of inclusion criteria. 
3. Section 4.3, Study Termination; Section 6.2.3, Instruction to Participants for 
Handling Parsaclisib 
Description of change:  Added and modified descriptions specific to Japan. 
Rationale for change:  Added based on Japan GCP requirement(s). 
4. Section 5.1, Inclusion Criteria (Criterion 7); Section 8.5.3, Tissue Biopsies 
Description of change:  Added a sentence to allow enrollment without biopsy sample 
collected after the completion of last therapy. 
Rationale for change:  Modified to stimulate enrollment. 
5. Section 5.1, Inclusion Criteria (Criterion 11c); Appendix A, Information Regarding 
Effectiveness of Contraceptive Methods 
Description of change:  Changed the duration for avoiding fathering children from 
90 to 93 days. 
Rationale for change:  Modified to be consistent with the duration of refraining from 
donating sperm discussed in Inclusion Criterion 11C. 
6. Section 8.4.1, Blood Sample Collection 
Description of change:  Added explanation of meal information during 
 
sample visits in the eCRF. 
Rationale for change:  To obtain the information of meal. 


Incyte Biosciences Japan GK 
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7. Section 9.1, Definition of Adverse Event; Section 9.2, Definition of Serious Adverse 
Event; Section 9.3, Recording and Follow-Up of Adverse Events and/or Serious 
Adverse Events; Section 9.4, Reporting of Serious Adverse Events; Section 9.9, 
Product Complaints 
Description of change:  Modified language to align with the most updated protocol 
template. 
Rationale for change:  Updated based on current protocol template. 
8. Section 10.4.4.4, Electrocardiograms (Table 13:  Criteria for Clinically Notable 
Electrocardiogram Abnormalities) 
Description of change:  QTcB was deleted from table. 
Rationale for change:  QTcB was deleted to align with Exclusion Criterion 19. 
9. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the protocol and are noted in the redline version of the 
amendment. 


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Incyte Biosciences Japan GK 
Page 90 of 90 
Protocol INCB 50465-213 Am 4 
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24 JAN 2023 
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8. Section 8.3.1, Adverse Events 
Description of change:  Added nonserious AESIs to the follow-up details. 
Rationale for change:  Clarify the follow-up period of nonserious AESI. 
9. Section 8.3.6, Laboratory Assessments 
Description of change:  Removed statement regarding central laboratory assessments. 
Rationale for change:  Most laboratory testing will be performed locally in this study. 
10. Section 8.3.6.2, Pregnancy Testing 
Description of change:  Updated the description of pregnancy testing for location to be 
performed locally. 
Rationale for change:  Pregnancy test will be performed locally in this study. 
11. Section 8.3.6.3, Serology 
Description of change:  Deleted the statement regarding serology to be performed by a 
central laboratory. 
Rationale for change:  Serology assessment will be performed locally in this study. 
12. Section 9.3, Recording and Follow-Up of Adverse Events and/or Serious Adverse 
Events 
Description of change:  Updated the follow-up of AE details to be consistent with 
Section 8.3.1. 
Rationale for change:  Clarification and keep consistency with Section 8.3.1. 
13. Section 9.4, Reporting of Serious Adverse Events 
Description of change:  Changed description of SAE reporting method to be provided 
by EDC. 
Rationale for change:  Change in SAE reporting method. 
14. Section 10.2, Population for Analysis (Table 11:  Populations for Analysis) 
Description of change:  Deleted information regarding pharmacodynamics. 
Rationale for change:  No pharmacodynamics will be evaluated in this study. 
15. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the protocol and are noted in the redline version of the 
amendment. 


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SAP_001.pdf: 
Official Title:    A Phase 2, Multicenter, Open-Label Study of Parsaclisib, a PI3Kδ Inhibitor, 
in Japanese Participants With Relapsed or Refractory Follicular Lymphoma 
(CITADEL-213) 
NCT Number: 
NCT04434937 
Document Date: 
Statistical Analysis Plan Amendment 1: 26-January-2023


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Incyte Biosciences Japan GK 
Page 2 of 36 
INCB 50465-213 Statistical Analysis Plan Amendment 1 
26 JAN 2023 
VV-CLIN-013943 
CONFIDENTIAL 
TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
TABLE OF CONTENTS .................................................................................................................2 
LIST OF ABBREVIATIONS ..........................................................................................................5 
1. 
INTRODUCTION ........................................................................................................7 
2. 
STUDY INFORMATION, OBJECTIVES, AND ENDPOINTS.................................7 
2.1. 
Protocol and Case Report Form Version ......................................................................7 
2.2. 
Study Objectives and Endpoints ...................................................................................7 
3. 
STUDY DESIGN .........................................................................................................9 
3.1. 
Randomization ..............................................................................................................9 
3.2. 
Control of Type I Error .................................................................................................9 
3.3. 
Sample Size Considerations .......................................................................................10 
3.4. 
Schedule of Assessments ............................................................................................10 
4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS ..................................10 
4.1. 
Scheduled Study Evaluations and Study Periods .......................................................10 
4.1.1. 
Day 1 ...........................................................................................................................10 
4.1.2. 
Study Day ...................................................................................................................10 
4.1.3. 
Baseline Value ............................................................................................................10 
4.1.4. 
Handling of Missing and Incomplete Data .................................................................11 
4.2. 
Variable Definitions ....................................................................................................12 
4.2.1. 
Body Mass Index ........................................................................................................12 
4.2.2. 
Prior and Concomitant Medication .............................................................................12 
5. 
STATISTICAL METHODOLOGY ...........................................................................12 
5.1. 
General Methodology .................................................................................................12 
5.2. 
Treatment Groups .......................................................................................................12 
5.3. 
Analysis Populations ..................................................................................................12 
5.3.1. 
All-Screened Population .............................................................................................12 
5.3.2. 
Full Analysis Set .........................................................................................................13 
5.3.3. 
Safety Population ........................................................................................................13 
 
13 
6. 
BASELINE, EXPOSURE, AND DISPOSITION VARIABLES AND 
ANALYSES ...............................................................................................................13 
6.1. 
Baseline and Demographics, Physical Characteristics, and Disease History .............13 


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Incyte Biosciences Japan GK 
Page 9 of 36 
INCB 50465-213 Statistical Analysis Plan Amendment 1 
26 JAN 2023 
VV-CLIN-013943 
CONFIDENTIAL 
3. 
STUDY DESIGN 
This is a Phase 2, multicenter, open-label study evaluating parsaclisib treatment based on the 
primary endpoint of ORR.  Participants with relapsed or refractory FL (Grades 1, 2, or 3a) who 
have received at least 2 prior systemic therapies and who are ineligible HSCT will be screened 
for eligibility.  A total of approximately 40 participants will be enrolled, including approximately 
18 participants who have history of ASCT.  Participants will receive parsaclisib 20 mg QD for 
8 weeks followed by 2.5 mg QD.  Participants may receive treatment until disease progression, 
death, HSCT (if become eligible), unacceptable toxicity, or consent withdrawal, whichever 
occurs first.  Participants will be evaluated for ORR by an IRC and followed for CRR, DOR, 
PFS, OS, and safety.  Figure 1 presents the study design schema. 
An interim futility analysis is planned when the first 20 participants have been treated and 
evaluated for response or have been followed for at least 9 weeks or have permanently 
discontinued study treatment because of disease progression, withdrawal of consent, or death.  
The study will be terminated for futility if ≤ 7 of the 20 participants have responded (ie, CR or 
PR) based on assessments provided by the IRC; otherwise the study will continue.  A timely 
assessment of response will be performed to avoid the risk of overenrollment. 
Figure 1: 
Study Design 
 
3.1. 
Randomization 
Not applicable. 
3.2. 
Control of Type I Error 
No formal statistical tests will be performed.  Two-sided 95% CIs will be reported for all 
analyses when appropriate. 
No adjustment for alpha-spending is considered as there are no plans to stop the study early for 
overwhelming efficacy.  An IDMC will be assembled to monitor safety data and study conduct.  
The IDMC will also be charged with evaluating interim futility results.  See Section 10 for 
details regarding interim analyses conducted in this study. 


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3.3. 
Sample Size Considerations 
Approximately 40 participants will be enrolled.  If the true ORR is 62%, then with 40 total 
participants, there is approximately 90% probability of observing the lower bound of the 95% CI 
of ORR ≥ 35%. 
A historical examination of efficacy in the subgroup of patients with FL who received R-CHOP 
(or the equivalent) as their first therapy and experienced early relapse showed and ORR of 33% 
(Flinn et al 2019).  And previous studies of PI3K inhibitor for relapse or refractory FL set ORR 
of 30% to 40% as target.  Thus ORR of 35% is a clinically relevant target of patients with relapse 
or refractory FL (Flinn et al 2019, Dreyling et al 2017). 
3.4. 
Schedule of Assessments 
Refer to Protocol Amendment 4 dated 24 JAN 2023 for a full description of all study procedures 
and assessment schedules for this study. 
4. 
DATA HANDLING DEFINITIONS AND CONVENTIONS 
4.1. 
Scheduled Study Evaluations and Study Periods 
4.1.1. 
Day 1 
Day 1 is the date that the first dose of study drug (parsaclisib) is administered to the participants. 
4.1.2. 
Study Day 
If a visit/reporting date is on or after Day 1, then the study day at the visit/reporting date will be 
calculated as 
Day # = (Visit/Reporting Date – Day 1 date + 1). 
If the visit/reporting date is before Day 1, then the study day at the visit/reporting date will be 
calculated as 
Day # = (Visit/Reporting Date – Day 1 date). 
A study day of –1 indicates 1 day before Day 1. 
4.1.3. 
Baseline Value 
Baseline is the last nonmissing measurement obtained before the first administration of 
parsaclisib, unless otherwise defined. 
When scheduled assessments and unscheduled assessments occur on the same day and time of 
the assessment or time of first dose is not available, use the following convention to determine 
baseline: 
• If both a scheduled and an unscheduled visit are available on the day of the first dose 
and the time is missing, use the scheduled assessment as baseline. 
• If all scheduled assessments are missing on the day of the first dose and an 
unscheduled assessment is available, use the unscheduled assessment as baseline. 


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4.1.4. 
Handling of Missing and Incomplete Data  
In general, values for missing data will not be imputed unless methods for handling missing data 
are specified in this section or relevant sections.  The original reported dates collected on the 
eCRF should be used in all relevant listings.  The following rules will be used for handling 
missing or partial dates for analyses requiring dates. 
When calculating time since initial diagnosis of cancer, partial diagnosis date will be handled in 
the calculation as follows: 
• If only the day is missing, then the first day of the month will be used. 
• If both the month and day are missing, then 01 JAN will be used. 
• Otherwise, the time since diagnosis will not be calculated. 
When the date of the last dose is used in deriving variables such as duration of treatment or 
TEAE flag, missing or partial date of last dose will be handled in the calculation as follows: 
• If only the day is missing, then the earlier date of the last day of the month or the date 
that the participant discontinued treatment will be used. 
• If both the month and day are missing, then the earlier date of 31 DEC of the year or 
the date that the participant discontinued treatment will be used. 
• Otherwise, the date that the participant discontinued treatment will be used as the date 
of the last dose. 
When calculating DOR, PFS, and OS, a partial date of death will be handled in the calculation as 
follows: 
• If mmyyyy for the last known alive date = mmyyyy for the death date, then the day 
after the last known alive date will be used. 
• If mmyyyy for the last known alive date < mmyyyy for the death date, then the first 
day of the death month will be used. 
• Otherwise, the partial death date will not be handled. 
When calculating time to onset or duration of a TEAE, a partial or missing AE onset/end date 
will be handled in the calculation as follows: 
• If only the day is missing, then the first day of the month or Day 1, whichever is later, 
will be used as the onset date; the earlier date of the last day of the month or the date 
that the participant discontinued study or died will be used as the end date. 
• If both the month and day are missing, then 01 JAN or Day 1, whichever is later, will 
be used as the onset date; the earlier date of 31 DEC or the date that the participant 
discontinued study or died will be used as the end date. 
• Otherwise, Day 1 will be used as the onset date, and the missing end date will not be 
handled. 


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4.2. 
Variable Definitions 
4.2.1. 
Body Mass Index 
Body mass index will be calculated as follows: 
BMI (kg/m2) = [weight (kg)] / [height (m)]2. 
4.2.2. 
Prior and Concomitant Medication 
Prior medication is defined as any nonstudy medication started before the first dose of 
parsaclisib. 
Concomitant medication is defined as any nonstudy medication that is started accordingly: 
• Before the date of first administration of parsaclisib and is ongoing throughout the 
study or ends on/after the date of first study drug administration. 
• On/after the date of first administration of parsaclisib and is ongoing or ends during 
the course of study. 
A prior medication could also be classified as "both prior and concomitant medication" if the end 
date is on or after first dose of parsaclisib.  In the listing, it will be indicated whether a 
medication is prior-only, concomitant-only, or both prior and concomitant. 
For the purposes of analysis, all medications will be considered concomitant medications unless 
the medications can unequivocally be defined as not concomitant. 
5. 
STATISTICAL METHODOLOGY 
5.1. 
General Methodology 
Unless otherwise noted, SAS® software (SAS Institute Inc, Cary, NC; v9 or later) will be used 
for the generation of all tables, graphs, and statistical analyses.  Descriptive summaries for 
continuous variables will include, but not be limited to, the number of observations, mean, 
standard deviation, median, minimum, and maximum.  Descriptive summaries for categorical 
variables will include the number and percentage of participants in each category. 
Interim analyses are planned for this study as defined in Section 10. 
5.2. 
Treatment Groups 
This is a Phase 2, multicenter, open-label study.  For the purpose of analysis, the 2.5 mg QD 
dosing period is considered a maintenance dosing period.  All data will be presented in summary 
tables by initially assigned treatment. 
5.3. 
Analysis Populations 
5.3.1. 
All-Screened Population 
The all-screened population includes all participants who signed the informed consent form.  The 
all-screened population will be used for the summary of analysis populations. 


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6.1.3. 
Prior Therapy 
Number of prior systemic cancer therapy regimens will be summarized for all participants in the 
FAS.  The component drugs of prior systemic therapy regimens will be coded using the WHO 
Drug Dictionary.  Number and percentage of participants with each drug will be summarized by 
WHO drug class and WHO drug PT.  Regimen name, component drugs, start and stop date, route 
of the medication, best response, reason for discontinuation, and date of relapse/progression will 
be listed. 
Number of participants who received prior radiation will be summarized for the FAS.  
Radiotherapy type, anatomical location of the administration, start and stop date, reason for 
regimen, best response, and total dose will be listed. 
Number of participants who had prior surgery or surgical procedure for the malignancy under 
study will be summarized for the FAS.  Date and description of the surgery/procedure will be 
listed. 
Number of participants who had prior hematopoietic stem cell transplant will be summarized for 
the FAS.  Date of transplant, type of transplant, source of cells, line of therapy, best response, 
date of relapse/progression, and regimen and drug used with the transplant will be listed. 
6.1.4. 
Medical History 
Medical history will be coded to SOC and PT using MedDRA coding dictionary.  For 
participants in the FAS, medical history will be summarized by SOC and PT and listed. 
6.2. 
Disposition of Participants 
The number and percentage of participants who were treated, who were ongoing with study 
treatment, who discontinued study treatment with a primary reason for discontinuation, who 
were still in the study, and who withdrew from the study with a primary reason for withdrawal 
will be summarized for the FAS. 
The number of participants enrolled by site will also be provided for the FAS. 
6.3. 
Protocol Deviations 
Protocol deviations recorded on the eCRF will be summarized and listed for the FAS. 
6.4. 
Exposure 
For participants in the safety population, exposure to parsaclisib will be summarized 
descriptively as the following: 
• Duration of treatment (days):  Date of last dose – date of first dose + 1.  Duration of 
treatment in months will be calculated based on the assumption that the average 
month has 30.4375 days.  The number and percentage of participants in each duration 
category (≥ 6 months, ≥ 12 months, ≥ 18 months, ≥ 24 months as applicable) will be 
summarized. 
• Duration of treatment during the initial QD dosing period (days):  Date of last 
dose during initial QD dosing period – date of first dose + 1. 


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• Duration of treatment during the maintenance dosing period (days):  Date of last 
dose – date of first dose during the maintenance dosing period + 1. 
• Average reported daily dose during the initial QD dosing period (mg/day):  Total 
reported dose taken during initial QD dosing period (mg) / duration of treatment 
during the initial QD dosing period (days). 
• Average reported daily dose during the maintenance dosing period (mg/day):  
Total reported dose taken during the maintenance dosing period (mg) / duration of 
treatment during the maintenance dosing period (days). 
• Dose modifications:  Number of participants who had dose reduction and 
interruption will be summarized.  The number of dose reductions and the number of 
interruptions for each participant will be summarized. 
6.5. 
Study Drug Compliance 
For participants in the safety population, overall compliance (%) for parsaclisib will be 
calculated for all participants as 
compliance (%) = 100  [total dose actually taken] / [total prescribed dose]. 
The total prescribed dose is defined as the sum of the doses prescribed by the investigator 
accounting for dose modifications. 
The total actual dose taken will be calculated based on information entered on the Drug 
Accountability CRF.  If there are dispensed drugs that have not been returned yet, the actual dose 
taken starting from the dispense date of the unreturned drugs will be imputed by the dose taken 
as reported on the dosing CRF. 
6.6. 
Prior and Concomitant Medication 
Prior medications and concomitant medications will be coded using the WHO Drug Dictionary.  
Number and percentage of participants in the FAS for each prior and concomitant medication 
will be summarized by WHO drug class and WHO drug PT. 


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7. 
EFFICACY 
Appendix A provides a list of planned tables, figures, and listings.  Sample data displays are 
included in a separate document. 
7.1. 
Efficacy Hypotheses 
Not applicable. 
7.2. 
Response Assessment 
An objective assessment of disease status is required at baseline (screening) using the CT-based 
response criteria of the Lugano Classification (Cheson et al 2014).  Disease status will be 
subsequently assessed by CT/MRI every 8 weeks through Week 24, then every 12 weeks 
through Week 96, and then every 24 weeks thereafter until disease progression. 
Bone marrow examination is required as a baseline assessment at screening except for reasons 
provided in Section 8.2.2 of the Protocol.  If disease is present in bone marrow at baseline, a 
bone marrow examination will be required to confirm CR or may be performed as clinically 
indicated.  If the bone marrow does not have lymphoma involvement at baseline, a repeat 
marrow examination is not required to confirm indication of CR on imaging.  All bone marrow 
examination should include a unilateral aspiration and biopsy, when feasible. 
Sites will use the CT-based response criteria of the Lugano Classification (Cheson et al 2014) to 
assess response to treatment locally.  At each postbaseline disease assessment, response will be 
collected in the eCRF as CR, PR, SD, PD, or NE. 
All imaging will be submitted to the IRC.  Imaging data and applicable clinical data will be 
reviewed and response will be assessed using the CT-based response criteria of the Lugano 
Classification (Cheson et al 2014) by independent reviewers as described in the Independent 
Review Charter.  An overall timepoint response at each postbaseline disease assessment, the best 
overall response, the date of initial response (if applicable), and the date of progression along 
with the reason(s) of disease progression (if applicable) for each participant, considering 
radiographic data and clinical data, will be provided by the clinical reviewer.  These data will be 
used in the analyses of related efficacy endpoints. 
7.3. 
Analysis of the Primary Efficacy Parameter 
The primary efficacy analysis will be conducted when the last patient in the FAS has been 
followed for 12 months from the first dose of treatment. 
7.3.1. 
Best Overall Response and Overall Response Rate 
For responses determined by the IRC, the best overall response for each participant will be 
provided by the clinical reviewer.  A participant is considered an objective responder if they have 
a best overall response of CR or PR. 
The ORR is the proportion of objective responders.  Participants who do not have sufficient 
baseline or on-study response assessment information to be adequately assessed for response 
status will be included in the denominators in the calculation of ORR. 


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Best overall response as determined by the IRC will be descriptively summarized.  The ORR as 
determined by the IRC will be estimated with 95% CIs.  Confidence intervals will be calculated 
based on the exact method for binomial distributions. 
When applicable, sensitivity analysis of ORR as determined by the IRC may be provided 
excluding participants who do not have evaluable radiological images at baseline per the IRC. 
7.3.2. 
Subgroup Analyses for Objective Response Rate 
Subgroups will be formed based on the following participant characteristics and baseline 
variables for those participants whose data are available: 
• Age:  < 65 years, ≥ 65 years 
• Gender:  male, female 
• Current FL grade:  1, 2, 3a 
• Current Ann Arbor Staging:  I-II, III-IV 
• Current FLIPI risk category:  low (0 - 1), intermediate (2), high (≥ 3) 
• Number of prior systemic therapy regimens:  2, ≥ 3 
• Bone marrow involvement at baseline:  yes, no, unknown 
• ECOG performance status:  ≤ 1 versus 2 
• Bulky disease at baseline:  longest diameter ≥ 10 cm vs < 10 cm at baseline by IRC 
• Relapsed/refractory status to the most recent prior therapy:  relapsed, refractory, 
unknown 
• Prior history of ASCT:  yes, no 
Subgroups may be further divided, combined, or eliminated based on emerging data.  The ORR 
as determined by IRC and its 95% exact binomial CIs will be provided for participants for each 
subgroup.  A forest plot will be created to summarize the variability in ORR as determined by 
the IRC for participants across subgroups. 
7.4. 
Analysis of the Secondary Efficacy Parameters 
7.4.1. 
Complete Response Rate 
Complete response rate is the percentage of participants with a best overall response of CR as 
defined by revised response criteria for lymphomas (Cheson et al 2014).  For responses 
determined by the IRC, the best overall response for each participant will be provided by the 
clinical reviewer.  Participants who do not have sufficient baseline or on-study response 
assessment information to be adequately assessed for response status will be included in the 
denominators in the calculation of CRR. 
The CRR as determined by the IRC will be estimated with 95% CIs.  Confidence intervals will 
be calculated based on the exact method for binomial distributions. 


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7.4.2. 
Duration of Response 
Duration of response is defined as the time from first documented evidence of CR or PR until 
disease progression or death due to any cause among participants who achieve an objective 
response (ie, CR or PR), as determined by revised response criteria for lymphomas 
(Cheson et al 2014).  For responses assessed by the IRC, the date of initial response and date of 
disease progression will be provided by the clinical reviewer for participants who have achieved 
best response of CR or PR.  Censoring of DOR will follow the same algorithm as the censoring 
of PFS (see Section 7.4.3). 
The total number of responders per the IRC, the number of participants whose disease 
progressed per the IRC or who died, and the number of participants censored will be 
summarized.  The Kaplan-Meier estimate of median DOR as determined by the IRC will be 
presented with its 95% CI, with the CIs calculated using the generalization of Brookmeyer and 
Crowley's method (1982) with log-log transformation (Klein and Moeschberger 1997). 
7.4.3. 
Progression-Free Survival 
Progression-free survival is defined as the time from the date of the first dose of the study drug to 
the first documented disease progression as determined by revised response criteria for 
lymphomas (Cheson et al 2014), or death due to any cause, whichever occurs first.  For 
responses assessed by IRC, date of disease progression will be provided by the Clinical 
Reviewer.  Censoring for PFS will follow the algorithm outlined in Table 2, which is based on 
FDA Guidance for Industry:  Clinical Trial Endpoints for the Approval of Non-Small Cell Lung 
Cancer Drugs and Biologics (2015) and Guidance for Industry:  Clinical Trial Endpoints for the 
Approval of Cancer Drugs and Biologics (2018). 
The number of participants whose disease progressed per the IRC or who died, and the number 
of participants censored will be summarized.  The Kaplan-Meier estimate of median PFS as 
determined by the IRC will be presented with its 95% CIs, with the CIs calculated using the 
generalization of Brookmeyer and Crowley's method (1982) with log-log transformation 
(Klein and Moeschberger 1997).  Progression-free survival rates at 6, 12, 18, and 24 months will 
also be provided with 95% CIs calculated using Greenwood's formula to estimate the standard 
error. 


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Table 2: 
Evaluation and Censoring of Progression-Free Survival 
Situation 
Outcome 
Date of Progression or Censoring 
No baseline tumor assessments 
Censored 
Day 1 
No valid postbaseline response 
assessments 
Censored 
Day 1 
Progression documented between 
scheduled response assessments 
Progressed 
Date of first overall response of PD 
No progression 
Censored 
Date of last valid radiologic assessment 
(not NE and not missing) 
Study discontinuation for 
undocumented progression 
Censored 
Date of last valid radiologic assessment 
(not NE and not missing) 
Study discontinuation for toxicity 
or other reason 
Censored 
Date of last valid radiologic assessment 
(not NE and not missing) 
New anticancer treatment started 
Censored 
Date of last valid radiologic assessment 
(not NE and not missing) on/before starting a new 
anticancer treatment 
Death before first progressive 
response assessment 
Progressed 
Date of death 
Death between adequate response 
assessments 
Progressed 
Date of death 
Death or progression after two or 
more missed assessments 
Censored 
Date of last valid radiologic assessment (not NE 
and not missing) before the missed assessments 
NE = not evaluable. 
7.4.4. 
Overall Survival 
Overall survival is defined as the time from the date of the first dose of study drug to death due 
to any cause.  For participants who are still alive at the time of the analysis, OS will be censored 
on the date the participant is last known to be alive. 
The number of participants who died and the number of participants censored will be 
summarized.  The Kaplan-Meier estimate of median OS will be presented with its 95% CIs, with 
the CIs calculated using the generalization of Brookmeyer and Crowley's method (1982) with 
log-log transformation (Klein and Moeschberger 1997).  Survival rates at 6, 12, 18, and 
24 months will also be provided with 95% CIs calculated using Greenwood's formula to estimate 
the standard error. 
7.4.5. 
Best Percentage Change in Target Lesion Size 
For participants in the FAS with measurable lesions at baseline, target lesion sizes will be 
measured by the sum of the product of diameters of all target lesions.  The best percentage 
change from baseline, defined as the largest decrease in target lesion sizes on/before new 
anti-lymphoma therapy during the study, will be summarized.  A waterfall plot of the best 
percentage change will be generated using data from the IRC.  Note that for participants who 


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9. 
SAFETY AND TOLERABILITY 
Appendix A provides a list of planned tables, figures, and listings.  Sample data displays are 
included in a separate document. 
9.1. 
General Considerations 
Summary tables may be replaced with listings when appropriate.  For instance, an AE frequency 
table may be replaced with a listing if it only contains a few unique PTs reported on relatively 
few participants. 
9.2. 
Adverse Events 
9.2.1. 
Adverse Event Definitions 
A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the 
first dose of study drug and within 30 days of the last administration of study drug regardless of 
starting new anti-lymphoma therapy.  Analysis of AEs (as discussed below) will be limited to 
TEAEs, but data listings will include all AEs regardless of their timing in relation to study drug 
administration.  For purposes of analysis, all AEs will be considered TEAEs unless the AE can 
unequivocally be defined as not treatment-emergent. 
Adverse events will be tabulated by MedDRA PT and SOC.  Severity of AEs will be graded 
using the NCI CTCAE (v5.0; NCI 2017), Grades 1 through 5.  The CTCAE reporting guidelines 
and grading details are available on the Cancer Therapy Evaluation Program website. 
The subset of AEs considered by the investigator to be related to study drug will be considered 
treatment-related AEs.  If the investigator does not specify the relationship of the AE to study 
drug, the AE will be considered treatment-related.  The incidence of AEs and treatment-related 
AEs will be tabulated.  In addition, serious TEAEs will also be tabulated. 
9.2.2. 
Adverse Events of Special Interest 
The number of participants who experienced TEAEs of special interest listed below will be 
summarized by maximum severity. 
• Colitis 
• Diarrhea 
• Exfoliative dermatitis 
• Febrile neutropenia 
• Rash 
• Intestinal perforation 
• Pneumonitis 
• Pneumonia 
• PJP infection 
• CMV infection 


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• Herpes simplex  
• Varicella zoster virus infection 
The time to onset of a TEAE is defined as the interval between the date of first dose of study 
drug and the date of the first occurrence of a TEAE.  Participants who have not experienced a 
TEAE at the time of analysis will be right-censored at the earlier of 30 days after the last dose 
date and date of last study visit through the end of safety follow-up.  If participants have missing 
or partial last dose dates of study drug or onset date of a TEAE, the partial or missing dates will 
be handled using the rules explained in Section 4.1.4. 
Summaries of time to onset of new or worsening Grade 3 or higher AEs will be provided using 
descriptive statistics and the life-table method for rash, colitis, diarrhea, febrile neutropenia, 
pneumonia, herpes simplex, and varicella zoster virus infection.  In addition, summaries of time 
to onset of new or worsening AEs of any grade will be provided using descriptive statistics and 
the life-table method for colitis, diarrhea, exfoliative dermatitis, intestinal perforation, 
pneumonia, pneumonitis, PJP infection, CMV infection, herpes simplex, and varicella zoster 
virus infection.  Kaplan-Meier plots of time to onset of new or worsening Grade 3 or higher AEs 
will be provided for rash, colitis, and diarrhea.  In addition, Kaplan-Meier plots of time to onset 
of new or worsening AEs of any grade will be provided for colitis and diarrhea. 
Descriptive statistics of time to onset of these TEAEs of special interest are based on all 
participants who have experienced a TEAE at the time of analysis.  To summarize these TEAEs 
of special interest using the life-table method, the effective sample size is defined as the number 
of participants at the beginning of interval minus half the participants censored in the interval.  
The conditional proportion is calculated as the number of first events divided by the effective 
sample size in the interval.   
The longest duration of a TEAE of any grade is defined as the longest interval between the date 
of occurrence of a TEAE and the date of resolution.  The longest duration of a Grade 3 or higher 
TEAE is defined as the longest interval between the date of occurrence of a Grade 3 or higher 
TEAE and the date of improvement to Grade 2 or lower.  If participants have missing or partial 
onset/end date of a TEAE, the partial or missing dates will be handled using the rules explained 
in Section 4.1.4.  Participants who have missing end date of a TEAE at the time of analysis will 
be right-censored using the following algorithm: 
• If the TEAE is serious, then the participant will be censored at the earlier date of data 
cutoff, study discontinuation, and death. 
• If the TEAE is not serious,  
− 
If the participant is ongoing with study treatment, then the participant will be 
censored at the data cutoff date, OR  
− If the participant discontinued treatment, then the participant will be censored at 
date of safety follow-up visit, or 35 days after the end of treatment visit (or after 
the last dose if the end of treatment visit was not performed), whichever is later; 
the censored date will be truncated by the earlier date of data cutoff, study 
discontinuation, and death if beyond. 


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Longest duration of new or worsening Grade 3 or higher colitis, diarrhea, rash, and febrile 
neutropenia will be summarized.  In addition, longest duration of new or worsening AEs of any 
grade will be summarized for colitis, diarrhea, and rash. 
The total number of participants whose TEAE of any grade resolved or whose Grade 3 or higher 
TEAE improved to Grade 2 or lower and the number of participants censored will be 
summarized.  The Kaplan-Meier estimate of median time to resolution/improvement and its 
95% CIs will be provided, with the CIs calculated using the generalization of Brookmeyer and 
Crowley’s method (1982) with log-log transformation (Klein and Moeschberger 1997).  
Resolution/improvement rates at selected timepoints will also be provided with 95% CIs 
calculated using Greenwood's formula to estimate the standard error. 
TEAEs of special interest to be summarized may be adjusted based on emerging data. 
9.2.3. 
Adverse Event Summaries 
Overall summaries of TEAEs will be provided during the parsaclisib initial QD dosing period, 
maintenance dosing period, and overall period (ie, all TEAEs regardless of the timing of 
occurrence).  These summaries will include the following: 
• Number (%) of participants reporting any TEAEs 
• Number (%) of participants reporting any Grade 3 or higher TEAEs 
• Number (%) of participants reporting any serious TEAEs 
• Number (%) of participants reporting any TEAEs related to parsaclisib 
• Number (%) of participants reporting any Grade 3 or higher TEAEs related to 
parsaclisib 
• Number (%) of participants reporting any serious TEAEs related to parsaclisib 
• Number (%) of participants who had TEAE with fatal outcome 
• Number (%) of participants with parsaclisib dose reductions because of TEAEs 
• Number (%) of participants who temporarily interrupted parsaclisib because of 
TEAEs 
• Number (%) of participants who permanently discontinued parsaclisib because of 
TEAEs 
The following summaries will be produced for TEAEs during the overall period by MedDRA 
term (if 5 or fewer participants appear in a table, a listing may be appropriate): 
• Summary of TEAEs by SOC and PT 
• Summary of TEAEs by PT in decreasing order of frequency 
• Summary of TEAEs by SOC, PT, and maximum severity 
• Summary of TEAEs by PT and maximum severity in decreasing order of frequency 
• Summary of Grade 3 or higher TEAEs by SOC and PT 
• Summary of Grade 3 or higher TEAEs by PT in decreasing order of frequency 


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• Summary of serious TEAEs by SOC and PT 
• Summary of serious TEAEs by PT in decreasing order of frequency 
• Summary of parsaclisib treatment-related TEAEs by SOC and PT 
• Summary of parsaclisib treatment-related TEAEs by PT in decreasing order of 
frequency 
• Summary of parsaclisib treatment-related TEAEs by SOC, PT, and maximum 
severity 
• Summary of Grade 3 or higher parsaclisib treatment-related TEAEs by SOC and PT 
• Summary of parsaclisib treatment-related serious TEAEs by SOC and PT 
• Summary of TEAEs with a fatal outcome by SOC and PT 
• Summary of TEAEs leading to parsaclisib dose reduction by SOC and PT 
• Summary of TEAEs leading to parsaclisib dose interruption by SOC and PT 
• Summary of TEAEs leading to discontinuation of parsaclisib by SOC and PT 
• Summary of selected TEAEs of special interest by maximum severity 
• Summary of time to onset of selected TEAEs of special interest 
• Summary of time to onset of selected TEAEs of special interest:  life-table method 
• Summary of longest duration of selected TEAEs of special interest 
The following supporting summaries will be produced for TEAEs during the parsaclisib initial 
QD dosing period and the maintenance dosing period by MedDRA term.   
• Summary of TEAEs by PT in decreasing order of frequency 
• Summary of TEAEs by PT and maximum severity in decreasing order of frequency 
• Summary of Grade 3 or higher TEAEs by PT in decreasing order of frequency  
• Summary of serious TEAEs by PT in decreasing order of frequency 
• Summary of TEAEs with a fatal outcome by SOC and PT  
• Summary of TEAEs leading to discontinuation of parsaclisib by SOC and PT 
9.3. 
Clinical Laboratory Tests 
9.3.1. 
Laboratory Value Definitions 
Laboratory values and change from baseline values will be summarized descriptively by visit.  
Baseline will be determined according to Section 4.1.3.  If there are multiple values that meet the 
criteria for baseline, the value from the central laboratory has priority over the value from the 
local laboratory.  Thereafter, additional rules may be provided after consultation with the 
medical monitor to delineate which value will be defined as baseline. 


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Laboratory test values will be assessed for severity based on the numerical component of 
CTCAE v5.0. 
9.3.2. 
Laboratory Value Summaries 
All test results and associated normal ranges from central laboratories will be reported in SI 
units.  Any laboratory test results and associated normal ranges from local laboratories will be 
converted to SI units.   
When there are multiple laboratory nonmissing values for a participant's particular test at a 
scheduled visit, central laboratory values have higher priority over local laboratory values.  If a 
tie still exists, the laboratory value with the smallest laboratory sequence number will be used in 
by-visit summaries. 
Numeric laboratory values will be summarized descriptively in SI units, and non-numeric test 
values will be tabulated when necessary.  In addition, line graphs will be provided for ALT, 
AST, hemoglobin, platelet counts, leukocytes, neutrophils, and lymphocytes. 
Shift tables will be presented showing change in CTCAE grade from baseline to worst grade 
postbaseline.  Separate summaries for abnormally high and abnormally low laboratory values 
will be provided when the laboratory parameter has both high and low grading criteria.  The 
denominator for the percentage calculation will be the number of participants in the baseline 
category.  The number of participants who experienced worsening of laboratory abnormalities 
will be summarized by maximum postbaseline severity. 
9.3.3. 
Potential Hy's Law Events 
Participants with elevated ALT or AST > 3 × ULN range and alkaline phosphatase < 2 × ULN 
range accompanied by total bilirubin > 2 × ULN range at the same visit will be listed. 
9.3.4. 
Worsening Laboratory Events of Special Interest 
Laboratory events of special interest are listed below. 
• ALT increased 
• AST increased 
• Absolute neutrophil count decreased 
The time to onset of a worsening laboratory event is defined as the interval between the date of 
first dose of study drug and the date of the first occurrence of CTC grade worse than baseline for 
the laboratory event.  Participants who have not experienced a worsening laboratory event at the 
time of analysis will be right-censored at the last postbaseline study visit with nonmissing CTC 
grade of the laboratory event. 
Time to onset of worsening Grade 3 or 4 laboratory events of special interest will be summarized 
using descriptive statistics and the life-table method as described in Section 9.2.2, and the 
Kaplan-Meier plot of time to onset of worsening Grade 3 or 4 absolute neutrophil count 
decreased will be provided.  Laboratory events of special interest to be summarized may be 
adjusted based on emerging data. 


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9.4. 
Vital Signs 
Values at each scheduled visit, change, and percentage change from baseline for vital signs, 
including weight, systolic blood pressure, diastolic blood pressure, pulse, body temperature, and 
respiratory rate will be summarized descriptively. 
Normal ranges for vital sign values are defined in Table 4.  The abnormal values for participants 
exhibiting vital sign abnormalities will be listed along with their assigned treatment regimen.  
Alert vital signs are defined as an absolute value outside the defined normal range and 
percentage change greater than 25%.  Note that the definition of alert vital signs does not apply 
for body temperature and weight.  The abnormal values for participants exhibiting alert vital sign 
abnormalities will be listed. 
Table 4: 
Normal Ranges for Vital Sign Values 
Parameter 
High Threshold 
Low Threshold 
Systolic blood pressure 
≤ 155 mmHg 
≥ 85 mmHg 
Diastolic blood pressure 
≤ 100 mmHg 
≥ 40 mmHg 
Pulse 
≤ 100 bpm 
≥ 45 bpm 
Temperature 
≤ 38°C 
≥ 35°C 
Respiratory rate 
≤ 24 breaths/min 
≥ 12 breaths/min 
9.5. 
Electrocardiograms 
Twelve-lead ECGs including PR, QRS, QT, QTcB, QTcF, and RR intervals will be obtained for 
each participant during the study.  Values at each scheduled visit, change, and percentage change 
from baseline will be summarized for each ECG parameter.  Baseline will be determined as the 
average of all nonmissing values before the first administration of parsaclisib. 
Normal ranges for ECG values are defined in Table 5.  Electrocardiogram values will also be 
considered abnormal if the absolute percentage change from baseline is more than 25% (30% for 
QRS interval).  Participants exhibiting ECG abnormalities will be listed with study visit and 
assigned treatment regimen.  Abnormal values for participants with alert ECG values, defined as 
both the absolute value and the percentage change from baseline being outside normal ranges, 
will be identified and listed.  Outliers of QT, QTcB, and QTcF values, defined as absolute values 
> 450 milliseconds or change from baseline > 30 milliseconds, will be summarized. 
Table 5: 
Normal Ranges for Electrocardiogram Values 
Parameter 
High Threshold 
Low Threshold 
PR 
≤ 220 ms 
≥ 75 ms 
QRS 
≤ 120 ms 
≥ 50 ms 
QT 
≤ 500 ms 
≥ 300 ms 
QTcB, QTcF 
≤ 450 ms 
≥ 295 ms 
RR 
≤ 1330 ms 
≥ 600 ms 
QTcB = Bazett's correction; QTcF = Fridericia's correction. 


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10. 
INTERIM ANALYSES 
An interim futility analysis is planned when the first 20 participants have been evaluated for 
response or have been followed for at least 9 weeks or have permanently discontinued study 
treatment because of disease progression, withdrawal of consent, or death.  The study will be 
terminated for futility if ≤ 7 of the 20 participants have responded (ie, CR or PR) based on 
assessments provided by the IRC; otherwise the study will continue.  The probability of stopping 
at interim for futility is 60.10% when the true response rate is 35% or 1.32% when the true 
response rate is 62%. 
An IDMC will be charged with evaluating interim futility results.  The IDMC will consist of 
clinicians and an independent statistician.  The IDMC will make recommendations to the sponsor 
at the planned interim futility analysis.  The process by which the IDMC will make 
recommendations and decisions will be documented in the IDMC charter.  Additional 
operational details of the interim analyses, including tables, figures, and listings provided to the 
IDMC, will be provided in the IDMC Charter. 
There is no efficacy interim analysis planned for the study as there are no plans to stop the study 
early for overwhelming efficacy. 


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11. 
CHANGES AND MODIFICATIONS TO THE ANALYSIS PLAN 
All versions of the SAP are listed in Table 6. 
Table 6: 
Statistical Analysis Plan Versions 
SAP Version 
Date 
Original 
22 MAR 2021 
Amendment 1 
26 JAN 2023 
11.1. 
Changes to Protocol-Defined Analyses 
Not applicable. 
11.2. 
Changes to the Statistical Analysis Plan 
Amendment 1 (26 JAN 2023): 
Overall Rationale for the Amendment:  The minimum observation period required for 
evaluation of the primary endpoint (ORR) was updated based on the time to response data from a 
non-Japanese study. This modification led to the SAP Amendment 1 reflecting this change. 
• Section 7.3 has been modified to include the timing of the primary analysis. 
 


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12. 
REFERENCES 
Brookmeyer R, Crowley J. A confidence interval for the median survival time. Biometrics 
1982;38:29-41. 
Cheson BD, Fisher RI, Barrington SF, et al. Recommendations for initial evaluation, staging, and 
response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin 
Oncol 2014;32:3059-3068. 
Dreyling M, Santoro A, Mollica L, et al. Phosphatidylinositol 3-kinase inhibition by copanlisib 
in relapsed or refractory indolent lymphoma. J Clin Oncol 2017;35:3898-3950. 
Flinn IW, Miller CB, Ardeshna KM, et al. DYNAMO: a Phase II study of duvelisib (IPI-145) in 
patients with refractory indolent non-Hodgkin lymphoma. J Clin Oncol 2019;37:912-922. 
Klein JP, Moeschberger ML. Survival analysis: techniques for censored and truncated data, New 
York, NY: Springer-Verlag; 1997. 
National Cancer Institute. Common Terminology Criteria for Adverse Events Version 5.0. 2017. 


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Incyte Biosciences Japan GK 
Page 34 of 36 
INCB 50465-213 Statistical Analysis Plan Amendment 1 
26 JAN 2023 
VV-CLIN-013943 
CONFIDENTIAL 
Table No. 
Title 
Population 
Standard 
3.2.26 
Summary of Selected Treatment-Emergent Adverse Events of Special 
Interest by Maximum Severity 
Safety 
 
3.2.27 
Summary of Time to Onset of Selected Treatment-Emergent Adverse 
Events of Special Interest 
Safety 
 
3.2.28 
Summary of Time to Onset of Selected Treatment-Emergent Adverse 
Events of Special Interest:  Life-Table Method 
Safety 
 
3.2.29 
Summary of Longest Duration of Selected Treatment-Emergent Adverse 
Events of Special Interest 
Safety 
 
3.3.1.1 
Summary of Laboratory Values - Hematology 
Safety 
X 
3.3.1.2 
Summary of Laboratory Values - Chemistry 
Safety 
X 
3.3.3.1 
Shift Summary of Hematology Laboratory Values in CTC Grade - To 
the Worst Abnormal Value 
Safety 
X 
3.3.3.2 
Shift Summary of Chemistry Laboratory Values in CTC Grade - To the 
Worst Abnormal Value 
Safety 
X 
3.3.3.4 
Treatment-Emergent Worsening of Laboratory Abnormalities - 
Hematology 
Safety 
X 
3.3.3.5 
Treatment-Emergent Worsening of Laboratory Abnormalities - 
Chemistry 
Safety 
X 
3.3.6 
Time to Onset of Treatment-Emergent Worsening of Laboratory Events 
of Special Interest 
Safety 
 
3.3.7 
Time to Onset of Treatment-Emergent Worsening of Laboratory Events 
of Special Interest:  Life-Table Method 
Safety 
 
3.4.1 
Summary of Systolic Blood Pressure 
Safety 
X 
3.4.2 
Summary of Diastolic Blood Pressure 
Safety 
X 
3.4.3 
Summary of Pulse 
Safety 
X 
3.4.4 
Summary of Respiratory Rate 
Safety 
X 
3.4.5 
Summary of Body Temperature 
Safety 
X 
3.4.6 
Summary of Weight 
Safety 
X 
3.5.1 
Summary of PR Interval (ms) From 12-Lead ECG 
Safety 
X 
3.5.2 
Summary of QRS Interval (ms) From 12-Lead ECG 
Safety 
X 
3.5.3 
Summary of QT Interval (ms) From 12-Lead ECG 
Safety 
X 
3.5.4 
Summary of QTcB Interval (ms) From 12-Lead ECG 
Safety 
X 
3.5.5 
Summary of QTcF Interval (ms) From 12-Lead ECG 
Safety 
X 
3.5.6 
Summary of RR Interval (ms) From 12-Lead ECG 
Safety 
X 
3.5.8 
Summary of Outliers of QT, QTcB, and QTcF Interval Values From 
12-Lead ECG 
Safety 
X 
3.5.9 
Summary of Clinically Significant ECG Abnormality 
Safety 
X 
Figures 
Figure No. Title 
4.1.1 
Forest Plot of Objective Response Rate as Determined by Independent Review Committee 
4.2.1 
Kaplan-Meier Estimates of Duration of Response as Determined by Independent Review Committee 
4.2.2 
Kaplan-Meier Estimates of Duration of Response as Reported by Investigator 
4.2.3 
Kaplan-Meier Estimates of Progression-Free Survival as Determined by Independent Review 
Committee 
4.2.4 
Kaplan-Meier Estimates of Progression-Free Survival as Reported by Investigator 
4.2.5 
Kaplan-Meier Estimates of Overall Survival 


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Incyte Biosciences Japan GK 
Page 36 of 36 
INCB 50465-213 Statistical Analysis Plan Amendment 1 
26 JAN 2023 
VV-CLIN-013943 
CONFIDENTIAL 
Listing 
No. 
Title 
2.7.4 
Fatal Adverse Events 
2.7.5 
Treatment-Related Adverse Events 
2.7.6 
Adverse Events Leading to Interruption, Reduction or Discontinuation of Parsaclisib 
2.8.1 
Clinical Laboratory Values - Hematology 
2.8.2 
Clinical Laboratory Values - Chemistry 
2.8.3 
Abnormal Clinical Laboratory Values - Hematology 
2.8.4 
Abnormal Clinical Laboratory Values - Chemistry 
2.8.5 
Potential Hy's Law Events 
2.9.1 
Vital Signs 
2.9.2 
Abnormal Vital Sign Values 
2.9.3 
Alert Vital Sign Values 
2.10.1 
12-Lead ECG Values 
2.10.2 
Abnormal 12-Lead ECG Values 
2.10.3 
Alert 12-Lead ECG Values