A Randomized, Double-Blind Study Evaluating the Efficacy, Safety and Immunogenicity of ABP 798 Compared With Rituximab in Subjects With CD20 Positive B-Cell Non-Hodgkin Lymphoma (NHL)
Phase: PHASE3
Conditions: Lymphoma, Non-Hodgkin
Sponsor: Amgen

Product: ABP 798 
Clinical Study Protocol: 20130109 
Date: 17 July 2017  
Page 1 of 69 
Confidential
1 
TITLE PAGE 
A RANDOMIZED, DOUBLE-BLIND STUDY EVALUATING THE EFFICACY, 
SAFETY AND IMMUNOGENICITY OF ABP 798 COMPARED WITH 
RITUXIMAB IN SUBJECTS WITH CD20 POSITIVE B-CELL NON-HODGKIN 
LYMPHOMA (NHL) 
Test Drug: 
ABP 798 
Protocol Number: 
20130109 
EudraCT number:  2013-005542-11 
Study Phase:  
3 
Date and Version: 
5.0, 17 July 2017  
Key Contact: 
Amgen Inc.: 
Clinical Research Organization (CRO): 
Clinical Research Study Manager 
Amgen Inc. 
One Amgen Center Drive 
Thousand Oaks, CA USA 
91320 
Phone:
Email: 
PhD 
Senior Project Director 
PRA Health Sciences 
500 South Oak Way, Green Park 
Reading, Berkshire, RG2 6AD UK 
Phone:
Mobile:
Email: 
Safety Contact: 
PRA Drug Safety Center 
North America 
Phone: 1-800-772-2215 
Fax:  1-888-772-6919 
E-mail: CHOSafety@prahs.com
Europe, Asia, and Pacific Region 
Phone:  +49.621.878.2154 
FAX:  +44 1792 525 720 
MHGSafety@prahs.com 
This study will be conducted in compliance with the protocol, Good Clinical Practice 
(GCP) as set forth in the International Council for Harmonisation (ICH) guidelines on 
GCP (ICH E6), and applicable local regulatory requirements. 
CONFIDENTIAL 
This document is a confidential communication of Amgen, Inc. Acceptance of this document constitutes 
agreement by the recipient that no unpublished information contained herein shall be published or 
disclosed without prior written approval, except that this document may be disclosed to the appropriate 
Institutional Review Board(s)/Independent Ethics Committee(s) under the condition that they keep it 
confidential. 
NCT Number: NCT02747043
This NCT number has been applied to the document for
purposes of posting on clinicaltrials.gov

Product: ABP 798 
Clinical Study Protocol: 20130109 
Date: 17 July 2017 
SIGNATURES 
Page 2 of 69 
Representatives of Sponsor and Clinical Research Organization 
I have read and agree to the protocol20130109, titled "A Randomized, Double-blind Study 
Evaluating the Efficacy, Safety and lmmunogenicity of ABP 798 Compared with Rituximab 
in Subjects with CD20 Positive 8-cell Non-Hodgkin Lymphoma (NHL)." I am aware of my 
responsibilities under the guidelines of GCP, local regulations (as applicable) and the 
study protocol. I agree to conduct the study according to these responsibilities. 
Accepted for the Sponsor- Amgen Inc.: 
Print Name 
Title 
Signature 
Date 
Accepted for the Clinical Research Organization - PRA: 
Print Name 
Title 
Sign
Date 
Confidential 

Product: ABP 798 
Clinical Study Protocol: 20130109 
Date: 17 July 2017  
Page 3 of 69 
Confidential
Investigator 
I have read and agree to the protocol 20130109, entitled “A Randomized, Double-blind 
Study Evaluating the Efficacy, Safety and Immunogenicity of ABP 798 Compared with 
Rituximab in Subjects with CD20 Positive B-cell Non-Hodgkin Lymphoma (NHL).”  I am 
aware of my responsibilities as an Investigator under the guidelines of GCP, local 
regulations (as applicable) and the study protocol.  I agree to conduct the study according 
to these responsibilities and to appropriately direct and assist the staff under my control, 
who will be involved in the study. 
Clinical Site:  
Site Number: 
Site Principal Investigator: 
Print Name 
Title 
Signature
Date
Coordinating Investigator Signature (if applicable): 
Print Name 
Title 
Institution/ Country 
Signature
Date

Product: ABP 798 
Clinical Study Protocol: 20130109 
Date: 17 July 2017  
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2 
SYNOPSIS 
NAME OF SPONSOR:  Amgen  
PROTOCOL No.: 20130109 
NAME OF STUDY TREATMENT:  ABP 798 
TITLE OF STUDY: A Randomized, Double-blind Study Evaluating the Efficacy, Safety, and 
Immunogenicity of ABP 798 Compared with Rituximab in Subjects with CD20 Positive B-cell Non-
Hodgkin Lymphoma (NHL) 
STUDY CENTERS:  Approximately 150 sites in Europe, North America, Latin America, and Asia 
Pacific  
STUDY PERIOD:  Approximately 250 subjects will be randomized in a 
1:1 ratio to receive ABP 798 or rituximab (Rituxan®).  The clinical study 
will be completed when the last subject completes the week 28 visit or 
withdraws early from the study.  
PHASE OF 
DEVELOPMENT:  
Phase 3 
PLANNED STUDY DATES: The study consists of a screening period of up to 4 weeks and a 
treatment period of 28 weeks, for a total of up to 32 weeks.  The expected enrollment duration is 
approximately 24 months.  
OBJECTIVES:  
Primary Objective:  The primary objective for this study is to evaluate the efficacy of ABP 798 
compared with rituximab. 
 
Secondary Objective(s):  The secondary objective is to assess the pharmacokinetics (PK), 
pharmacodynamics, safety, tolerability, and immunogenicity of ABP 798 compared with rituximab. 
 
STUDY DESIGN AND METHODOLOGY:  This is a randomized, double-blind study in adult 
subjects with Grade 1, 2, or 3a follicular B-cell non-Hodgkin lymphoma (NHL) and low tumor 
burden.  Approximately 250 subjects (125 per treatment group) will be randomized (1:1) to 
receive investigational product (IP) (ABP 798 or rituximab) at a dose of 375 mg/m2 administered 
as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.  
Tumor assessment will be performed at baseline and weeks 12 and 28.  Subjects will be stratified 
by geographic area and age (> 60 vs ≤ 60 years).  
A subject will remain on study until week 28.  Subjects who discontinue IP before week 20 will be 
followed for 8 weeks after the last dose of IP and then complete the end-of-study visit. 
An independent data monitoring committee (DMC) will evaluate the safety data throughout the 
study, including an initial safety review after the first 12 subjects have received at least 2 doses of 
IP.  
STUDY POPULATION AND MAIN CRITERIA FOR INCLUSION/EXCLUSION:  
Inclusion Criteria:  
Subjects cannot be randomized before all inclusion criteria (including test results) are confirmed. 
1. Males and females 18 years of age and older 
2. Histological confirmed (by lymph node or extranodal region biopsy), Grade 1, 2, or 3a 
follicular B-cell NHL expressing CD20 within 12 months before randomization 
3. Stage 2, 3, or 4 (per Cotswold’s Modification of Ann Arbor Staging System; Appendix 3) 
with measurable disease (per International Working Group) 
 
subjects must have a baseline scan (computed tomography [CT]) of the neck (if 
palpable lymph node > 1.0 cm), chest, abdomen, and pelvis to assess disease 
burden within 6 weeks before randomization 
 
subjects must have had a baseline bone marrow biopsy within 12 months before 
randomization.  Previously confirmed positive bone marrow involvement does not 
need to be repeated for purposes of screening. 
4. Low tumor burden based on the Groupe d'Etudes des Lymphomes Folliculaires (GELF) 
criteria (Appendix 4) 
 
largest nodal or extranodal mass ≤ 7 cm 
 
no more than 3 nodal sites with diameter > 3 cm 
 
no splenomegaly > 16 cm by CT scan and no symptomatic splenomegaly 
 
no significant pleural or peritoneal serous effusions by CT 
 
lactate dehydrogenase ≤ upper limit of normal (ULN)  

Product: ABP 798 
Clinical Study Protocol: 20130109 
Date: 17 July 2017  
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 
no B symptoms (night sweats, fever [temperature > 38°C], weight loss > 10% in the 
previous 6 months)  
5. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1  
6. Blood counts: 
 
absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1,500/μL) 
 
lymphocytes < 1.5 x the ULN 
 
platelets ≥ 100 x 109/L (100,000/μL) 
 
hemoglobin ≥ 10.0 g/dL 
7. Adequate hepatic function as defined by: 
 
total bilirubin < 1.5 x the ULN 
 
aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2 x ULN 
 
Subjects with an elevated unconjugated bilirubin (Gilbert's syndrome) will be eligible 
if hepatic enzymes and function are otherwise within normal limits (ie, AST, ALT, and 
alkaline phosphatase are within normal limits) and there is no evidence of hemolysis. 
8. Adequate renal function as defined by creatinine < 1.5 x ULN or estimated creatinine 
clearance ≥ 50 mL/min calculated by the Cockcroft-Gault method 
9. Subjects must sign an Institutional Review Board/Independent Ethics 
Committee-approved informed consent form before any study specific procedures. 
 
Exclusion Criteria: 
If any of the following apply, the subject MUST NOT enter the study: 
 
1. Diffuse large cell component and/or Grade 3b follicular NHL 
2. History or known presence of central nervous system metastases 
3. Palliative radiotherapy within 3 months before randomization 
4. Malignancy other than NHL within 5 years (except treated in-situ cervical cancer, or 
squamous or basal cell carcinoma of the skin) 
5. Major surgical procedure within 4 weeks before randomization or planned major surgical 
procedure during the treatment phase 
6. Any of the following in the 6 months before randomization:  
 
clinically significant cardiovascular disease (including myocardial infarction, unstable 
angina, symptomatic congestive heart failure [New York Heart Association 
≥ Class III], serious uncontrolled cardiac arrhythmia); peripheral vascular disease, 
cerebrovascular accident, or transient ischemic attack  
7. Medically uncontrolled hypertension or systolic blood pressure > 160 mmHg or diastolic 
blood pressure > 100 mmHg 
8. Known active or history of active tuberculosis (TB) 
9. Positive for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus 
antibody at screening   
10. Known to be human immunodeficiency virus positive 
11. Recent infection requiring a course of systemic anti-infective agents that was completed 
≤ 7 days before randomization (with the exception of uncomplicated urinary tract 
infection)  
12. Other investigational procedures that can impact the study data, results, or patient 
safety while participating in this study are excluded; participation in observational 
studies is allowed. 
13. Subject is currently enrolled in or has not yet completed at least 30 days or 5 half-lives 
(whichever is longer) since ending other investigational device or drug study(s), including 
vaccines, or subject is receiving other investigational agent(s) 
14. Previous use of either commercially available or investigational chemotherapy, biological, 
or immunological therapy for NHL (including rituximab or biosimilar rituximab, or other 
anti-CD20 treatments) 
15. Systemic corticosteroid use within 3 months before randomization (inhaled are 
allowable) 
16. Live vaccines within 28 days prior to the first dose of IP 
17. History of neurologic symptoms suggestive of central nervous system demyelinating 
disease 

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Date: 17 July 2017  
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18. Woman of childbearing potential who is pregnant or is breastfeeding 
19. Woman of childbearing potential who does not consent to use highly effective methods of 
birth control (eg, true abstinence, sterilization, birth control pills, Depo Provera injections, 
or contraceptive implants) during treatment and for an additional 12 months after the last 
administration of the protocol specified-treatment 
20. Man with a partner of childbearing potential who does not consent to use highly effective 
methods of birth control (eg, true abstinence, vasectomy, or a condom in combination 
with hormonal birth control or barrier methods used by the woman) during treatment and 
for an additional 12 months after the last administration of the protocol specified 
treatment 
21. Subject has known sensitivity to any of the products to be administered during the study, 
including mammalian cell derived drug products 
22. Subject previously has been randomized in this study 
23. Subject likely to not be available to complete all protocol-required study visits or 
procedures 
24. History or evidence of any other clinically significant disorder, condition or disease (with 
the exception of those outlined above) that, in the opinion of the Investigator or Amgen 
physician, if consulted, would pose a risk to subject safety or interfere with the study 
evaluation, procedures or completion 
NUMBER OF SUBJECTS:  Approximately 250 subjects will be randomized in a 1:1 ratio to 
receive ABP 798 or rituximab. 
 
 
 
 
STUDY TREATMENT(S):  
Test Product, Dose and Mode of Administration: 
ABP 798 at a dose of 375 mg/m2 administered as an IV infusion weekly for 4 weeks followed by 
dosing at weeks 12 and 20. 
Reference Therapy, Dose and Mode of Administration: 
Rituximab at a dose of 375 mg/m2 administered as an IV infusion weekly for 4 weeks followed by 
dosing at weeks 12 and 20. 
DURATION OF TREATMENT:  The study includes a screening period of up to 4 weeks.  
Subjects will receive IP at day 1 (visit 1) and weeks 2 (visit 2), 3 (visit 3), 4 (visit 4), 12 (visit 5), 
and 20 (visit 6) and will have an end-of-study visit at week 28.  Individual total study duration will 
be 32 weeks.   
STUDY EVALUATIONS:  
Primary Efficacy Criterion:  
 
Risk difference of ORR by week 28  
Secondary Efficacy Criteria: 
 
Risk difference of ORR at week 12 
Pharmacokinetic and Pharmacodynamic Criteria: 
 
Percentage of subjects with complete depletion of CD19+ cell count from baseline to study 
day 8 and total IgG and IgM antibody levels 
 
Serum concentrations at predose and immediately after the end of infusion at week 12  
Safety Criteria:  
 
Treatment-emergent adverse events (AEs) and serious AEs (SAEs) 
 
Clinically significant changes in laboratory values and vital signs 
 
Incidence of antidrug antibodies  
 
On study progression-free survival (PFS) 
 
On study overall survival (OS) 
STATISTICAL METHODS:  

Product: ABP 798 
Clinical Study Protocol: 20130109 
Date: 17 July 2017  
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Clinical equivalence of the primary endpoint will be demonstrated by first assessing non-inferiority 
by comparing the 1-sided 95% lower confidence interval (CI) limit of the RD of ORR by week 28 
between ABP 798 and rituximab with a -15% margin.  If the test of non-inferiority is successful, 
then the study will sequentially assess non-superiority by comparing the 1-sided 95% upper CI 
limit of the RD of ORR by week 28 with a 35.5% margin.  Additionally, a 2-sided 95% CI will be 
calculated and evaluated against a symmetrical margin of 15% for noninferiority and 
nonsuperiority.  The CIs for RD will be estimated using a generalized linear model adjusted for 
stratification factors.  Analyses of efficacy endpoints will be conducted on the full analysis set 
(consisting of all randomized subjects) according to randomized treatment. 
In addition, categorical variables will be summarized using the number and percentage of 
subjects falling into each category.  Continuous variables will be summarized using mean, 
standard error or standard deviation, median, minimum, maximum, and number of subjects with 
observations.   
Pharmacokinetics endpoints will be summarized as point estimates of the geometric mean ratio 
and 90% CIs of test (ABP 798)-to-reference (rituximab).  The pharmacodynamic endpoint of 
percentage of subjects with complete depletion of CD19+ cell count from baseline to study day 8 
will be summarized descriptively.  Pharmacokinetics and pharmacodynamic endpoints will be 
conducted on safety analysis set (consisting of subjects receiving at least 1 dose of IP) according 
to actual treatment received. 
Safety endpoints will be summarized descriptively as well.  Subgroup analyses (by gender, race, 
and stratification factors as appropriate) may be presented.  Safety will be assessed in the safety 
analysis set with treatment assignment based on actual treatment received.  All verbatim terms 
for any reported AEs will be coded to the appropriate system organ class and preferred term 
according to the current version of the Medical Dictionary for Regulatory Activities dictionary, and 
graded by the Investigator for severity as per Common Toxicity Criteria for Adverse Events 
version 4.03.  The number and percentage of subjects reporting AEs (all, serious, related, and 
deaths), and developing antidrug antibodies will be tabulated by treatment.  Vital signs and 
laboratory data will also be summarized descriptively by visit and treatment.  The safety 
endpoints of PFS and OS will be analyzed including all events up to the time of the last subject’s 
end-of-study visit.  Median PFS and OS time and survival curves may also be estimated using 
Kaplan-Meier methods.  Descriptive 1-sided 95% and 97.5% CIs on the hazard ratios of PFS and 
OS will be estimated based on Cox models, stratified by stratification factors. 
Independent safety reviews will be performed by the DMC periodically throughout the study, 
including an initial safety review after the first 12 subjects have received at least 2 doses of IP.  
Blinded study data will also be monitored on an ongoing basis by the blinded clinical study team 
to ensure subjects’ safety. 
DATE AND VERSION: 5.0, 17 July 2017  
 

Product: ABP 798 
Clinical Study Protocol: 20130109 
Date: 17 July 2017  
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3 
TABLE OF CONTENTS 
1 
TITLE PAGE .................................................................................................. 1 
2 
SYNOPSIS ..................................................................................................... 4 
3 
TABLE OF CONTENTS ................................................................................. 8 
4 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ....................... 12 
5 
ETHICS ........................................................................................................ 14 
5.1 
Ethics Committee ......................................................................................... 14 
5.2 
Ethical Conduct of the Study ........................................................................ 14 
5.3 
Subject Information and Consent ................................................................. 14 
6 
INTRODUCTION .......................................................................................... 16 
6.1 
Disease Review ............................................................................................ 16 
6.2 
Rituximab ..................................................................................................... 17 
6.3 
Compound Review ....................................................................................... 17 
6.4 
Study Rationale ............................................................................................ 17 
7 
STUDY OBJECTIVES ................................................................................. 19 
7.1 
Primary Study Objective ............................................................................... 19 
7.2 
Secondary Study Objectives ........................................................................ 19 
8 
INVESTIGATIONAL PLAN .......................................................................... 20 
8.1 
Overall Study Design and Plan .................................................................... 20 
8.2 
Discussion of Study Design .......................................................................... 21 
8.3 
Study Duration .............................................................................................. 21 
8.4 
Study Population .......................................................................................... 22 
8.4.1 
Inclusion Criteria ........................................................................................... 22 
8.4.2 
Exclusion Criteria ......................................................................................... 22 
8.4.3 
Withdrawal and Replacement of Subjects .................................................... 24 
8.4.3.1 
Criteria for Subject Withdrawal ..................................................................... 24 
8.4.3.2 
Evaluations at Withdrawal ............................................................................ 24 
8.4.3.3 
Replacement of Subjects ............................................................................. 25 
8.5 
Treatment ..................................................................................................... 25 
8.5.1 
Treatments Administered ............................................................................. 25 
8.5.2 
Study Treatment Formulation ....................................................................... 26 
8.5.2.1 
Study Drug ................................................................................................... 26 
8.5.2.2 
Comparator .................................................................................................. 26 
8.5.3 
Study Treatment Labeling and Packaging ................................................... 27 
8.5.4 
Blinding of Study Medication ........................................................................ 27 
8.5.5 
Study Treatment Storage and Accountability ............................................... 27 
8.5.5.1 
Study Treatment Storage ............................................................................. 27 
8.5.5.2 
Study Treatment Accountability .................................................................... 27 
8.5.6 
Dose Adjustments, Dose Escalation and Stopping Rules ............................ 28 
8.5.6.1 
Dose Adjustments and Dose Escalations ................................................ 28 
8.5.6.2 
Stopping Rules ........................................................................................... 28 
8.5.7 
Prior and Concomitant Therapy ................................................................... 29 
8.5.8 
Treatment Compliance ................................................................................. 29 
8.5.9 
Assignment to Treatment ............................................................................. 29 
8.5.10 
Unblinding Procedures ................................................................................. 30 

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8.6
Efficacy and Safety Variables......................................................................30
8.6.1
Efficacy and Safety Measurements Assessed.............................................30
8.6.1.1
Efficacy Measurements...............................................................................33
8.6.1.2
Pharmacokinetic/Pharmacodynamic Endpoints...........................................33
8.6.1.3
Safety Measurements .................................................................................33
9
STUDY EVALUATIONS BY VISIT..............................................................34
9.1
Screening....................................................................................................34
9.1.1
Screen Failures...........................................................................................35
9.2
Baseline (Day 1, first day of administration of investigational product) ........35
9.3
Visit 2 (Week 2), Visit 3 (Week 3), and Visit 4 (Week 4) ..............................36
9.4
Visit 4a (Week 5): Optional PK Sampling ................................................37
9.5
Visit 5 (Week 12) and Visit 6 (Week 20)......................................................37
9.6
Week 28/End of Study ................................................................................38
10
METHODS OF ASSESSMENT...................................................................39
10.1
Response Assessments..............................................................................39
10.2
Pregnancy Test...........................................................................................39
10.3
Physical Examination..................................................................................40
10.4
Vital Signs...................................................................................................40
10.5
Electrocardiogram.......................................................................................40
10.6
Clinical Laboratory Testing..........................................................................41
10.7
Blood Samples for Pharmacokinetic Analysis .............................................42
10.8
Blood Samples for Pharmacodynamic Analysis ..........................................42
11
SAFETY DATA COLLECTION, RECORDING, AND REPORTING............43
11.1
Adverse Events...........................................................................................43
11.1.1
Definition of Adverse Events .......................................................................43
11.1.2
Reporting Procedures for Adverse Events ..................................................43
11.2
Serious Adverse Events..............................................................................44
11.2.1
Definition of Serious Adverse Events ..........................................................44
11.2.2
Reporting Procedures for Serious Adverse Events .....................................45
11.3
Events of Interest........................................................................................46
11.4
Pregnancy Reporting ..................................................................................46
12
DATA MANAGEMENT AND STATISTICAL ANALYSIS............................48
12.1
Data Management ......................................................................................48
12.2
Sample Size Estimation ..............................................................................48
12.3
Statistical Analysis Plan ..............................................................................48
12.4
Randomization............................................................................................48
12.5
Analysis Sets ..............................................................................................48
12.5.1
Full Analysis Set .........................................................................................49
12.5.2
Per-protocol Set..........................................................................................49
12.5.3
Safety Analysis Set .....................................................................................49
12.6
Statistical Methods......................................................................................49
12.6.1
Missing Data...............................................................................................49
12.6.2
Demographic and Baseline Data.................................................................49
12.6.3
Subject Disposition .....................................................................................49
12.6.4
Efficacy .......................................................................................................50

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12.6.5
Pharmacokinetics........................................................................................50
12.6.6
Pharmacodynamics ....................................................................................51
12.6.7
Safety .........................................................................................................51
12.6.7.1
Investigational Product Administration ........................................................51
12.6.7.2
Adverse Events...........................................................................................51
12.6.7.3
Immunogenicity...........................................................................................51
12.6.7.4
Progression-free Survival and Overall Survival ...........................................52
12.6.7.5
Concomitant Medications and Therapies ....................................................52
12.6.7.6
Clinical Laboratory Test ..............................................................................52
12.6.7.7
Vital Signs and Physical Examinations........................................................52
12.6.7.8
Electrocardiograms.....................................................................................52
12.6.8
Interim Analysis...........................................................................................52
12.6.9
Data Monitoring Committee.........................................................................53
13
MONITORING PROCEDURES (QUALITY ASSURANCE).........................54
13.1
Routine Monitoring......................................................................................54
13.2
Inspections and Auditing Procedures..........................................................54
14
STUDY MANAGEMENT AND MATERIALS...............................................56
14.1
Electronic Case Report Forms ....................................................................56
14.2
Data Collection............................................................................................56
14.3
Source Documents Maintenance ................................................................57
14.4
Record Maintenance...................................................................................57
14.5
Confidentiality .............................................................................................58
15
ADMINISTRATION PROCEDURES ...........................................................59
15.1
Regulatory Approval ...................................................................................59
15.2
Protocol Amendments.................................................................................59
15.3
Protocol Adherence and Deviations ............................................................60
15.4
Publication Policy........................................................................................60
15.5
Clinical Study Report...................................................................................61
15.6
Contractual and Financial Details................................................................61
15.7
Compensation.............................................................................................61
15.8
Discontinuation of the Study........................................................................61
15.9
Study Center File Management...................................................................61
16
REFERENCE LIST .....................................................................................63
17
APPENDICES.............................................................................................65
17.1
Appendix 1: Elements of Informed Consent ................................................65
17.2
Appendix 2: Response Determination by IWG (1999) Criteria.....................66
17.2.1.1
Complete Response ...................................................................................66
17.2.1.2
CR/unconfirmed..........................................................................................66
17.2.1.3
Partial Response.........................................................................................66
17.2.1.4
Stable Disease............................................................................................67
17.2.1.5
Relapsed Disease.......................................................................................67
17.2.1.6
Progressive Disease ...................................................................................67
17.3
Appendix 3: Cotswold Modification of Ann Arbor Staging System ...............68
17.4
Appendix 4: Groupe d’Etudes des Lymphomes Folliculaires (GELF) 
Criteria ........................................................................................................69

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LIST OF TABLES 
Table 1.  Schedule of Assessments and Procedures ................................................ 31 
 
LIST OF FIGURES 
Figure 1.  Study Diagram .............................................................................................. 21 
 

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4 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
Term 
Definition 
AE 
Adverse event  
ALT 
Alanine aminotransferase  
ANC 
Absolute neutrophil count 
AST 
Aspartate aminotransferase  
CFR 
Code of Federal Regulations 
CI 
Confidence interval 
CR 
Complete response 
CRO 
Clinical research organization 
CT 
Computed tomography 
CTCAE 
Common Toxicity Criteria for Adverse Events 
DMC 
Data Monitoring Committee 
ECG 
Electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
EOS 
End of study 
EOI 
Event of interest 
EU 
European Union 
FAS 
Full analysis set 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GELF 
The Groupe d’Etudes des Lymphomes Folliculaires criteria 
GMR 
Geometric mean ratio 
HBcAb 
Hepatitis B core antibody 
HBsAg 
Hepatitis B surface antigen 
HCV 
Hepatitis C virus 
HBV 
Hepatitis B virus 
ICF 
Informed consent form 
ICH 
International Council for Harmonisation 
IEC 
Independent Ethics Committee 
Ig 
Immunoglobulin 
IP 
Investigational Product 

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IRB 
Institutional Review Board 
IV 
Intravenous 
IWG 
International Working Group 
IXRS 
Interactive voice and web response system 
LDH 
Lactate dehydrogenase 
LPL 
Lymphoplasmacytoid lymphoma  
LPD 
Longest perpendicular diameter  
LVD 
Longest vertical dimension  
MedDRA 
Medical Dictionary for Regulatory Activities 
MZL 
Marginal zone lymphoma  
NHL 
Non-Hodgkin lymphoma  
ORR 
Overall response rate 
OS 
Overall survival 
PD 
Progressive disease  
PFS 
Progression-free survival 
PIN 
Personal Identification Number 
PK 
Pharmacokinetic(s) 
PR 
Partial response 
QTc 
Corrected QT interval 
RD 
Risk difference 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
SD 
Stable disease  
SLL 
Small lymphocytic lymphoma 
SOC 
System organ class 
SOP 
Standard operating procedures 
SPD 
Sum of the products  
SUSAR 
Suspected unexpected serious adverse reaction 
TB 
Tuberculosis  
ULN 
Upper limit of normal 
US 
United States  
WHO 
World Health Organization 
WM 
Waldenstrom macroglobulinemia  

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5 
ETHICS 
5.1 
Ethics Committee 
This study will be conducted in compliance with Institutional Review Board 
(IRB)/Independent Ethics Committee (IEC) and International Council for Harmonisation 
(ICH) Good Clinical Practice (GCP) Guidelines - including Title 21 Part 56 of the United 
States (US) Code of Federal Regulations (CFR) relating to IRBs/IECs and GCP as 
described in the US Food and Drug Administration (FDA) CFR (21 CFR § 50, 56, 312) - 
in accordance with applicable ICH regulations regarding clinical safety data 
management (E2A, E2B[R3]), European Community directives 2001/20, 2001/83, 
2003/94 and 2005/28 as enacted into local law, and with ICH guidelines regarding 
scientific integrity (E4, E8, E9, and E10).  In addition, this study will adhere to all local 
regulatory requirements, and requirements for data protection. 
Before initiating a trial/study, the Investigator/institution must have written and dated 
approval/favorable opinion from the IRB/IEC for the study protocol/amendment(s), 
written informed consent form (ICF), any consent form updates, subject recruitment 
procedures (eg, advertisements), any written information to be provided to subjects and 
a statement from the IRB/IEC that they comply with GCP requirements.  The IRB/IEC 
approval must identify the protocol version as well as the documents reviewed. 
5.2 
Ethical Conduct of the Study 
This study will be conducted in accordance with the Note for Guidance on GCP (ICH 
Harmonised Tripartite Guideline E6 (R1); FDA CFR (21 CFR § 50, 56, 312), the general 
principles indicated in the Declaration of Helsinki and all applicable regulatory 
requirements. 
5.3 
Subject Information and Consent 
The Investigator will explain the benefits and risks of participation in the study to each 
subject or the subject’s legally acceptable representative and obtain written informed 
consent.  Written informed consent must be obtained prior to the subject entering the 
study and before initiation of any study-related procedure (including administration of 
study drug).  
The Sponsor will provide a sample ICF, based on the elements of informed consent in 
Section 17.1.  The final, version dated form must be agreed to by the Sponsor and the 
IRB/IEC and will contain all elements in the sample form, in language readily understood 
by the subject.  Each subject’s original consent form, personally signed and dated by the 

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subject or by the subject’s legally acceptable representative, and by the person who 
conducted the informed consent discussion, will be retained by the Investigator.  The 
Investigator will supply all enrolled subjects with a copy of their signed ICF. 
The ICF may need to be revised during the study should important new information 
become available that may be relevant to the safety of the subject.  In this instance 
approval should always be given by the IRB/IEC and existing subjects informed of the 
changes and reconsented.  This is documented in the same way as previously 
described. 
The Investigator should, with the consent of the subject, inform the subject’s primary 
physician about participation in the clinical study as needed. 

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6 
INTRODUCTION 
6.1 
Disease Review 
Non-Hodgkin lymphoma (NHL) is the most common hematological malignancy, with 
69,740 new cases and 19,020 deaths expected in the United States (US) in 2013 
(American Cancer Society, 2013) and approximately 74,000 new cases and 31,000 
deaths annually in Europe (Ferlay et al, 2010).  Non-Hodgkin lymphoma comprises a 
diverse group of malignancies, most of B-cell origin (80% to 85%; Friedberg et al, 2008).  
Of the B-cell NHLs, 4 subtypes, follicular lymphoma, small lymphocytic lymphoma (SLL), 
lymphoplasmacytoid lymphoma (LPL)/Waldenstrom macroglobulinemia (WM), and 
marginal zone lymphoma (MZL), have differing pathological features (Swerdlow et al, 
2008), but are generally included among those characterized as indolent in nature 
because they have a slowly progressive natural history (Pileri et al, 2004).  Together 
these indolent lymphomas comprise approximately 30% to 40% of B-cell NHLs in North 
America and Europe (Morton et al, 2006).  
Follicular lymphoma is the second most common lymphoma diagnosed in the US and 
Western Europe.  The median age at diagnosis is 60 years, and there is a slight female 
predominance (approximately 54%; American Cancer Society, 2013).  Follicular 
lymphomas are malignant counterparts of normal germinal center B-cells (IARC, 2008).  
Approximately 85% of patients with follicular lymphoma have t(14;18), which results in 
the overexpression of the BCL-2 protein, a member of a family of proteins that blocks 
apoptosis.  However, it is likely that multiple genetic events are required for the 
development of follicular lymphoma.  Follicular lymphoma has the immunophenotype 
CD19-, CD20-, and CD22-positive and CD5-negative (Chen et al, 2012).  Patients with 
follicular lymphoma generally present with asymptomatic lymphadenopathy, with waxing 
and waning present for years.  Involvement of bone marrow is present in 70% of 
patients, whereas involvement of other normal organs is uncommon.  Less than 20% of 
patients present with B symptoms, and < 20% of patients present with an increased 
serum lactate dehydrogenase (LDH).  Involvement of the intestine is a unique site of 
presentation of this disease, usually early stage, and with a favorable prognosis 
(Schmatz et al, 2011).  
Less than 10% of patients with follicular lymphoma present with early stage (I/II) disease 
(Friedberg et al, 2006).  Radiation therapy is often recommended for limited stage 
follicular lymphoma.  If significant morbidity is possible from radiotherapy based on the 

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location of the disease area or if the patient chooses not to receive radiation, observation 
may be a reasonable alternative, especially for Stage II patients (Advani et al, 2004).  
The overwhelming majority of patients have advanced stage disease at diagnosis.  
Patients with asymptomatic follicular lymphoma do not require immediate treatment 
unless they have symptomatic nodal disease, compromised end organ function B 
symptoms, symptomatic extranodal disease, or cytopenias (Ardeshna et al, 2003).  The 
addition of anti-B-cell antibodies has meant a change in how asymptomatic or modestly 
symptomatic disease is treated.   
6.2 
Rituximab 
Rituximab (Rituxan®, MabThera®) is a genetically engineered chimeric murine/human 
monoclonal immunoglobulin (Ig)G1 kappa antibody directed against the B-cell specific 
CD20 antigen.  Rituximab monotherapy presents an opportunity to significantly delay 
disease progression and death with limited side effects (as compared to standard 
chemotherapy (Ardeshna et al, 2010; 2014).  Rituximab has changed the paradigm of 
treating follicular lymphoma, both as monotherapy and in combination with 
chemotherapy (usually in the symptomatic setting; Herold et al, 2007), resulting in an 
overall increase in survival of follicular lymphoma patients (Chen et al, 2012; Fischer et 
al, 2005).  Rituximab monotherapy is replacing watchful waiting as the first-line response 
to asymptomatic follicular lymphoma. 
6.3 
Compound Review 
ABP 798 is being developed as a biosimilar to Rituxan® (rituximab), for the treatment of 
NHL and other indications.  The active ingredient of ABP 798 is an anti-CD20 
monoclonal antibody that has the same amino acid sequence as rituximab and 
equivalent pharmacologic function based on comprehensive bioanalytical assays.  
ABP 798 has the same pharmaceutical form and dosage strength as US-licensed 
rituximab [rituximab (US), Rituxan®] and European Union (EU)-licensed rituximab 
[rituximab (EU), Mabthera®]. 
Refer to the Investigator’s Brochure for additional information.   
6.4 
Study Rationale 
Similarity of ABP 798 to rituximab has been shown using bioanalytical methods and pre-
clinical studies (refer to the Investigator’s Brochure for additional information).  As 
outlined in the guideline on similar biological medicinal products containing monoclonal 

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antibodies (EMA/CHMP/BMWP/403543/2010), applicants are expected to provide data 
on similarity of pharmacokinetics (PK)/pharmacodynamics, safety, and efficacy.   
In the US, EU, and much of the world, laws, regulations, and guidances have been or 
are being put in place to increase availability of biological treatments by developing and 
licensing biosimilar products (CHMP/437/04 Rev 1; EMEA/CHMP/BWP/247713/2012; 
EMEA/CHMP/BMWP/42832/2005 Rev 1; US FDA 2012a; US FDA 2012b).   
A biosimilar product, generally, is one that is highly similar to a licensed biologic 
reference product, and there are no clinically meaningful differences between the 
biosimilar and reference product in terms of safety, purity, and potency.  Biosimilarity is 
demonstrated by the totality of the evidence, including quality, nonclinical, and clinical 
evidence.  The quality and nonclinical data for ABP 798 and rituximab are summarized 
in the Investigator’s Brochure.  The current study is designed to evaluate efficacy, PK, 
and safety, specifically, to demonstrate that there is no clinically meaningful difference 
between ABP 798 and rituximab in terms of overall response rate (ORR), peak and 
trough drug concentration, complete depletion of CD19+ cell count, safety, and 
immunogenicity. 

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7 
STUDY OBJECTIVES  
7.1 
Primary Study Objective 
The primary objective for this study is to evaluate the efficacy of ABP 798 compared with 
rituximab. 
7.2 
Secondary Study Objectives 
The secondary objective is to assess the PK, pharmacodynamics, safety, tolerability, 
and immunogenicity of ABP 798 compared with rituximab. 

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8 
INVESTIGATIONAL PLAN 
8.1 
Overall Study Design and Plan 
This is a randomized, double-blind study in adult subjects with Grade 1, 2 or 3a follicular 
B-cell NHL and low tumor burden.  Approximately 250 subjects (125 per treatment 
group) will be randomized (1:1) to receive investigational product (IP) (ABP 798 or 
rituximab) at a dose of 375 mg/m2 administered as an intravenous (IV) infusion once 
weekly for 4 weeks followed by dosing at weeks 12 and 20.  Tumor assessment will be 
performed at baseline and weeks 12 and 28.  Subjects will be stratified by geographic 
area and age (> 60 vs  60 years).  
A subject will remain in the treatment phase until week 28.  Subjects who discontinue IP 
before week 20 will be followed for 8 weeks after the last dose of IP and then complete 
the end-of-study (EOS) visit. 
An independent data monitoring committee (DMC) will evaluate the safety data 
throughout the study, including an initial safety review after the first 12 subjects have 
received at least 2 doses of IP.   
 
 

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Figure 1.  Study Diagram 
 
* Response assessments at study weeks 12 and 28 
Wk = week  
8.2 
Discussion of Study Design 
This study is randomized and double-blinded to prevent bias in treatment allocation and 
in the subjective assessment of effect.  The assessment of the primary endpoint will be 
at week 28.  
8.3 
Study Duration 
The study includes a screening period of up to 4 weeks.  Subjects will receive IP at 
day 1 (visit 1) and weeks 2 (visit 2), 3 (visit 3), 4 (visit 4), 12 (visit 5), and 20 (visit 6) and 
will have an EOS visit at week 28.  There is an additional visit at week 5 (visit 4a) for 
subjects who have agreed to the optional additional PK sampling (see 
Section 9.4).  Individual total study duration will be 32 weeks.   
Enrollment will continue until approximately 250 subjects have been randomized to 
treatment.  The study will be completed when the last subject completes the week 28 
visit or withdraws early from the study. 

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8.4 
Study Population 
8.4.1 
Inclusion Criteria 
Subjects MUST satisfy all of the following entry criteria before they will be allowed to 
participate in the study: 
1. Males and females 18 years of age and older 
2. Histological confirmed (by lymph node or extranodal region biopsy), Grade 1, 2, or 
3a follicular B-cell NHL expressing CD20 within 12 months before randomization 
3. Stage 2, 3, or 4 (per Cotswold’s Modification of Ann Arbor Staging System; 
Appendix 3) with measurable disease (per International Working Group) 
 
subjects must have a baseline scan (computed tomography [CT]) of the neck (if 
palpable lymph node > 1.0 cm), chest, abdomen, and pelvis to assess disease 
burden within 6 weeks before randomization 
 
subjects must have had a baseline bone marrow biopsy within 12 months before 
randomization.  Previously confirmed positive bone marrow involvement does 
not need to be repeated for purposes of screening 
4. Low tumor burden based on the Groupe d'Etudes des Lymphomes Folliculaires 
(GELF) criteria (Appendix 4) 
 
largest nodal or extranodal mass ≤ 7 cm 
 
no more than 3 nodal sites with diameter > 3 cm 
 
no splenomegaly > 16 cm by CT scan and no symptomatic splenomegaly  
 
no significant pleural or peritoneal serous effusions by CT 
 
lactate dehydrogenase ≤ upper limit of normal (ULN)  
 
no B symptoms (night sweats, fever [temperature > 38°C], weight loss > 10% in 
the previous 6 months) 
5. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1  
6. Blood Counts: 
 
absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1,500/μL) 
 
lymphocytes < 1.5 x the ULN 
 
platelets ≥ 100 x 109/L (100,000/μL) 
 
hemoglobin ≥ 10.0 g/dL 
7. Adequate hepatic function as defined by: 
 
total bilirubin < 1.5 x the ULN  
 
aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 
< 2 x ULN 
 
Subjects with an elevated unconjugated bilirubin (Gilbert's syndrome) will be 
eligible if hepatic enzymes and function are otherwise within normal limits (ie, 
AST, ALT, and alkaline phosphatase are within normal limits) and there is no 
evidence of hemolysis. 
8. Adequate renal function as defined by creatinine < 1.5 x ULN or estimated creatinine 
clearance ≥ 50 mL/min calculated by the Cockcroft-Gault method 
9. Subjects must sign an IRB/IEC-approved ICF before any study specific procedures.  
 
8.4.2 
Exclusion Criteria 
If any of the following apply, the subject MUST NOT enter the study: 
1. Diffuse large cell component and/or Grade 3b follicular NHL 
2. History or known presence of central nervous system metastases 
3. Palliative radiotherapy within 3 months before randomization 

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4. Malignancy other than NHL within 5 years (except treated in-situ cervical cancer, or 
squamous or basal cell carcinoma of the skin) 
5. Major surgical procedure within 4 weeks before randomization or planned major 
surgical procedure during the treatment phase 
6. Any of the following in the 6 months before randomization: 
 
clinically significant cardiovascular disease (including myocardial infarction, 
unstable angina, symptomatic congestive heart failure [New York Heart 
Association ≥ Class III], serious uncontrolled cardiac arrhythmia); peripheral 
vascular disease, cerebrovascular accident, or transient ischemic attack 
7. Medically uncontrolled hypertension or systolic blood pressure > 160 mmHg or 
diastolic blood pressure > 100 mmHg 
8. Known active or history of active tuberculosis (TB) 
9. Positive for hepatitis B surface antigen (HbsAg), hepatitis B core antibody (HBcAb), 
or hepatitis C virus (HCV) antibody at screening 
10. Known to be human immunodeficiency virus positive 
11. Recent infection requiring a course of systemic anti-infective agents that was 
completed ≤ 7 days before randomization (with the exception of uncomplicated 
urinary tract infection)  
12. Other investigational procedures that can impact the study data, results, or 
patient safety while participating in this study are excluded; participation in 
observational studies is allowed. 
13. Subject is currently enrolled in or has not yet completed at least 30 days or 5 half-
lives (whichever is longer) since ending other investigational device or drug study(s), 
including vaccines, or subject is receiving other investigational agent(s) 
14. Previous use of either commercially available or investigational chemotherapy, 
biological, or immunological therapy for NHL (including rituximab or biosimilar 
rituximab, or other anti-CD20 treatments) 
15. Systemic corticosteroid use within 3 months before randomization (inhaled are 
allowable) 
16. Live vaccines within 28 days prior to the first dose of IP 
17. History of neurologic symptoms suggestive of central nervous system demyelinating 
disease 
18. Woman of childbearing potential who is pregnant or is breastfeeding 
19. Woman of childbearing potential who does not consent to use highly effective 
methods of birth control (eg, true abstinence, sterilization, birth control pills, Depo 
Provera injections, or contraceptive implants) during treatment and for an additional 
12 months after the last administration of the protocol-specified treatment 
20. Man with a partner of childbearing potential who does not consent to use highly 
effective methods of birth control (eg, true abstinence, vasectomy, or a condom in 
combination with hormonal birth control or barrier methods used by the woman) 
during treatment and for an additional 12 months after the last administration of the 
protocol specified treatment 
21. Subject has known sensitivity to any of the products to be administered during the 
study, including mammalian cell derived drug products 
22. Subject previously has been randomized in this study 
23. Subject likely to not be available to complete all protocol-required study visits or 
procedures 
24. History or evidence of any other clinically significant disorder, condition or disease 
(with the exception of those outlined above) that, in the opinion of the Investigator or 
Amgen physician, if consulted, would pose a risk to subject safety or interfere with 
the study evaluation, procedures or completion 
 

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8.4.3 
Withdrawal and Replacement of Subjects 
8.4.3.1 
Criteria for Subject Withdrawal 
Subjects have the right to withdraw from the study at any time and for any reason 
without prejudice to future medical care by the physician or at the institution. 
Subjects (or a legally acceptable representative) can decline to continue receiving IP 
and/or other protocol-required procedures at any time during the study.  If this occurs, 
the Investigator is to discuss with the subject the appropriate processes for 
discontinuation from IP.  Additionally, the subject should be followed and complete the 
EOS visit 8 weeks (±7 days) after the last dose of IP. 
Withdrawal of consent for a study means that the subject does not wish to receive 
further protocol-required therapies or procedures, and the subject does not wish to or is 
unable to continue further study participation.  Subject data up to withdrawal of consent 
will be included in the analysis of the study, and, where permitted, publicly available data 
can be included after withdrawal of consent.  The Investigator is to discuss with the 
subject appropriate procedures for withdrawal from the study.   
Reasons for removal of a subject from the study might include: 
 
disease progression 
 
subject request to end IP(s) administration  
 
safety concern (eg, due to an adverse event [AE], failure to follow contraception, 
and/or protocol requirements)  
 
pregnancy 
 
withdrawal of consent from study 
 
received proscribed therapy (eg, commercial rituximab, other anticancer 
therapy) 
 
decision by Sponsor  
8.4.3.2 
Evaluations at Withdrawal 
For any subject who is withdrawn before completing all treatment visits, the Investigator 
should: 
 
perform all the procedures scheduled for the EOS visit (ie, week 28 visit 
[Section 9.6]).  The week 28/EOS assessments will be performed 8 weeks 
(±7 days) after the last dose of IP (unless the subject withdraws consent to do 
so).  Computed tomography is only required at early withdrawal if it has not been 
performed within the previous 28 days.  Computed tomography is to be 
performed before the start of new anti-cancer treatment. 
 
complete all appropriate electronic case report form (eCRF) screens, providing 
the date of and explanation for the subject’s withdrawal/discontinuation. 
 
when indicated, arrange for appropriate follow up and/or alternative medical care 
of the discontinued subject.  

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8.4.3.3 
Replacement of Subjects 
Subjects who are withdrawn will not be replaced.   
8.5 
Treatment 
8.5.1 
Treatments Administered 
The Investigator must ensure that the IP will be used only in accordance with the 
protocol.  ABP 798 and rituximab will be considered the IP. 
Subjects will be randomly assigned to 1 of 2 treatment groups, as follows: 
 
ABP 798 at a dose of 375 mg/m2 administered as an IV infusion once weekly for 
4 weeks followed by dosing at weeks 12 and 20. 
 
rituximab at a dose of 375 mg/m2 administered as an IV infusion once weekly for 
4 weeks followed by dosing at weeks 12 and 20. 
ABP 798/rituximab will be administered after all other procedures are completed for each 
visit.  The dose for ABP 798/rituximab will be calculated based on the height and weight 
obtained within 8 days of visit 1 and the dose will remain the same throughout the 
study. 
Subjects should receive premedications before each infusion.  Premedications should be 
given according to local practice for administration of rituximab therapy.  
Investigational product will be administered only as an IV infusion by a healthcare 
professional with appropriate medical support to manage severe infusion reactions.  Do 
not administer as an IV push or bolus.   
Intravenous infusions should be performed according to local practice for administration 
of rituximab therapy.  The first dose should not be initiated at a rate greater than 
50 mg/hour.  In the absence of infusion toxicity, the infusion rate can be increased by 
50 mg/hour increments every 30 minutes, to a maximum of 400 mg/hour.  If the first 
dose is tolerated, subsequent infusions may be initiated at a rate of 100 mg/hour.  In the 
absence of infusion toxicity, the infusion rate can be increased by 100 mg/hour 
increments every 30 minutes, to a maximum of 400 mg/hour.   
All subjects will be monitored for hypersensitivity reactions to IP by assessment of vital 
signs (systolic and diastolic blood pressure, pulse, respiration rate, and temperature) at 
the following time points: 
 
before IP infusion on IP administration visit 1 and visit 2 
 
approximately every 60 minutes during IP infusion on IP administration visit 1 
and visit 2 
 
at the end of IP infusion on IP administration visit 1 and visit 2 

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 
at approximately 60 minutes after the end of IP infusion on IP administration 
visit 1 and visit 2 
Subjects with signs and symptoms of a hypersensitivity reaction to IP will have vital 
signs assessed and oxygen saturation monitored by pulse oximetry.   
Refer to Section 8.5.6 for IP infusion rate adjustments and stopping rules.  
Refer to the Investigator’s Brochure for ABP 798 or the Package Insert and Summary of 
Product Characteristics for rituximab to obtain additional information regarding the IP. 
A manual containing detailed information regarding the labeling, packaging, storage, 
preparation, and administration of each IP (ABP 798 and rituximab) is to be provided 
separately in the Pharmacy Guide. 
8.5.2 
Study Treatment Formulation 
8.5.2.1 
Study Drug 
ABP 798 is a genetically engineered chimeric murine/human monoclonal IgG1 kappa 
antibody directed against the CD20 antigen with an identical amino acid sequence to 
that of rituximab.  ABP 798 has an approximate molecular weight of 145 kD.  ABP 798 is 
produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient 
medium.  ABP 798 is a sterile, clear, preservative-free liquid concentrate for IV 
administration.  ABP 798 is supplied at a concentration of 10 mg/mL in either 
100 mg/10 mL or 500 mg/50 mL single-use vials.  The product is formulated in 
polysorbate 80 (0.7 mg/mL), sodium citrate dihydrate (7.35 mg/mL), sodium chloride 
(9 mg/mL) and Water for Injection.  The pH is 6.5. 
8.5.2.2 
Comparator 
Rituximab (Rituxan®) is a genetically engineered chimeric murine/human monoclonal 
IgG1 kappa antibody directed against the CD20 antigen.  Rituximab has an approximate 
molecular weight of 145 kD and a binding affinity for the CD20 antigen of approximately 
8.0 nM.  Rituximab is produced by mammalian cell (Chinese Hamster Ovary) 
suspension culture in a nutrient medium containing the antibiotic gentamicin.  
Gentamicin is not detectable in the final product.  Rituximab is a sterile, clear, colorless, 
preservative-free liquid concentrate for IV administration.  Rituximab is supplied at a 
concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-use vials.  
The product is formulated in polysorbate 80 (0.7 mg/mL), sodium citrate dihydrate 
(7.35 mg/mL), sodium chloride (9 mg/mL) and Water for Injection.  The pH is 6.5. 

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8.5.3 
Study Treatment Labeling and Packaging 
A manual containing detailed information regarding the labeling, packaging, storage, 
preparation, and administration of each IP (IP[s], comparator product[s], etc) are to be 
provided separately in the Pharmacy Guide. 
8.5.4 
Blinding of Study Medication 
Since the IP containers are different for ABP 798 and rituximab, IP (ABP 798 or 
rituximab) will be prepared by an unblinded Pharmacist, or designee, into a common IV 
preparation for administration to the subject.  Subjects, Amgen, designated PRA, and 
other clinical site staff will be blinded to the IP allocation for each subject.  
Randomization data will be kept strictly confidential, filed securely by the Sponsor (or 
designee), and accessible only to authorized persons per Sponsor (or designee)’s 
standard operating procedures (SOPs) until the time of unblinding.  Select PRA staff (eg, 
clinical research associates), not involved in the monitoring or the daily operations of the 
study, will be unblinded to subject IP allocation in order to perform IP accountability.   
For details of the emergency procedure for unblinding of individual subjects see 
Section 8.5.10, below. 
At randomization, randomization numbers will be assigned to each subject by the 
interactive voice and web response system (IXRS).   
8.5.5 
Study Treatment Storage and Accountability 
It is forbidden to use investigational drug material for purposes other than as defined in 
this protocol. 
8.5.5.1 
Study Treatment Storage 
IP should be stored in a secure limited access location.  ABP 798 and rituximab vials 
should be stored protected from direct sunlight at 2°C to 8°C and according to the 
storage and expiration information (where required) provided on the label that is affixed 
to the package containing the IP.  Do not freeze or shake. 
8.5.5.2 
Study Treatment Accountability 
All supplies of IP will be accounted for in accordance with GCP.  There will be an 
individual study drug accountability record for each subject and the Pharmacist, or 
designee, should maintain accurate records of the disposition of all study medication 
supplies received during the study.  These records should include the amounts and 
dates clinical drug supplies were received and destroyed/returned to Amgen or its 
designee.  If errors or damages in the clinical drug supply shipments occur, the 

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Investigator should contact Amgen or its designee immediately.  Copies of the study 
medication accountability records will be provided by each Investigator for inclusion in 
the Trial Master File after database lock.  The study monitor will periodically check the 
supplies of study medication held by the Investigator or pharmacist to verify 
accountability of all medication used. 
The Investigator will administer the medication only to the identified subjects of this 
study, according to the procedures described in this study protocol.  After the EOS, all 
unused medication and all medication containers should be destroyed on-site or 
returned to Amgen or its designee, as appropriate for destruction.  In either instance, 
complete documentation will be returned to the Sponsor. 
8.5.6 
Dose Adjustments, Dose Escalation and Stopping Rules 
8.5.6.1 
Dose Adjustments and Dose Escalations 
There are no recommended dose adjustments or escalations for IP (ABP 798 or 
rituximab).   
If any scheduled dose of IP in the first 4 visits (ie, visit 1, visit 2, visit 3, and visit 4) is 
delayed from the scheduled visit date (by more than 3 days), then the dose will be 
administered as soon as possible and subsequent doses will be adjusted accordingly to 
remain once per week from the adjusted dose date.   
Regardless of previous dose delays, doses at visits 5 and 6 should be given according 
to the original schedule on weeks 12 and 20.  If the scheduled dose for visits 5 and 6 is 
delayed by more than 15 calendar days from the scheduled visit date, then this will be 
considered a missed dose.  The next dose should be given on the next scheduled visit 
date. 
8.5.6.2 
Stopping Rules 
In the event of National Cancer Institute (US) Common Toxicity Criteria for Adverse 
Events (CTCAE) Grade 2, Grade 3, and Grade 4 infusion-related reactions, including 
events of allergic reaction, anaphylaxis, or cytokine release syndrome, the infusion 
should immediately stop, and medical therapy and supportive care deployed as 
appropriate for the presenting symptoms (eg, antihistamine, bronchodilators, oxygen, 
and vasopressors).  Symptoms may include shivering, tachycardia, nausea, rash, 
significant decrease in blood pressure, and dyspnea.  For Grade 2 and Grade 3 events 
that have resolved, infusion can be initially resumed at not more than 50% of the 
previous rate at the discretion of the investigator.  If a subject experiences a Grade 4 

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infusion-related reaction, IP will be discontinued and the subject will have an EOS visit 8 
weeks after the last dose of IP. 
Immediately stop the infusion for any subject developing tumor lysis syndrome.  
Administer supportive care as per local standard, including aggressive hydration with 
correction of electrolyte abnormalities, while monitoring renal function and fluid balance.  
Since initial improvement of clinical symptoms may be followed by deterioration, these 
patients should be closely monitored until tumor lysis syndrome and pulmonary 
infiltration have been resolved or ruled out.  In all subjects, the infusion should not be 
restarted until complete resolution of all symptoms.  The infusion can be initially resumed 
at not more than 50% of the previous rate.  
8.5.7 
Prior and Concomitant Therapy 
All of the following are prohibited at any time during the study: 
 
any non-study anti-cancer treatment (other than palliative radiotherapy to 
nonindex lesions) 
 
commercial rituximab  
 
any experimental (biological or non-biological) therapy (within or outside a 
clinical study) 
 
live and attenuated vaccinations 
 
Any other treatment (not explicitly excluded) which is considered necessary for the 
subject’s welfare may be given at the discretion of the Investigator. 
All subjects who discontinue the study medication should be offered alternative 
treatment if applicable.  Treatment should be given according to normal clinical practice, 
after the end-of-treatment (week 28) visit. 
8.5.8 
Treatment Compliance 
Investigational product will be administered by site staff and recorded in the eCRF and 
subject records.  Records of study medication used and intervals between visits will be 
kept during the study.  Drug accountability will be noted by the study monitor during site 
visits and at the completion of the study.  To maintain treatment blinding of the 
Investigator, IP dispensation should be delegated from the Investigator to a qualified 
individual under the Investigator’s supervision.  An up-to-date treatment 
inventory/dispensing record must be maintained. 
8.5.9 
Assignment to Treatment 
When subjects enter the screening period for the study, the Investigator (or designee) 
will contact the IXRS and receive a unique 11-digit subject identification number before 

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any study procedures are performed.  This number will be used to identify the subject 
throughout the clinical study and must be used on all study documentation related to that 
subject.  
 
 
 
  Signing of the ICF establishes entry into the 
screening period. 
The subject identification number must remain constant throughout the entire clinical 
study; it must not be changed at the time of rescreening, enrollment, or randomization.  
This number will not necessarily be the same as the randomization number assigned for 
the study. 
Upon completion of screening, the Investigator (or designee) will contact the IXRS to 
randomize the subject centrally to receive either ABP 798 or rituximab in a 1:1 manner.  
The randomization will be stratified by geographic region and age (> 60 vs  60 years). 
8.5.10 
Unblinding Procedures 
A subject’s treatment assignment should only be unblinded when knowledge of the 
treatment is essential for the further management of the subject on this study.  
Unblinding at the study site for any other reason will be considered a protocol deviation.  
The Investigator is strongly encouraged to contact the Amgen Medical Monitor (or 
designee) before unblinding any subject’s treatment assignment, but must do so within 
1 working day after the event. 
The identity of IP assigned to subject numbers or to individual boxes of IP will be 
available for emergency situations through the IXRS.  Authorized site staff will be 
provided with a unique Personal Identification Number (PIN) to access the IXRS to 
obtain unblinding information.  This PIN is unique to the individual and must not be 
shared. 
8.6 
Efficacy and Safety Variables 
8.6.1 
Efficacy and Safety Measurements Assessed 
A schedule of assessments and procedures is presented in Table 1. 

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Table 1.  Schedule of Assessments and Procedures  
 
Screen 
≤ 28 
days 
 
Treatment Phase 
End of Study
/Week 28  
(± 7 days) 
Visit 1 
Baseline 
Day 1, Week 
1 
Visit 2 
Week 2 
(± 3 days)
Visit 3 
Week 3 
(± 3 days)
Visit 4 
Week 4 
(± 3 days) 
OPTIONAL
Visit 4a 
Week 5 
(± 3 days)
Visit 5 
Week 12
(± 7 days)
Visit 6 
Week 20
(± 7 days)
General Assessments 
 
 
 
 
 
 
 
 
 
Informed consent form 
X 
 
 
 
 
 
 
 
 
Post-infusion observation (4 
hour) 
 
X a 
 
 
 
 
 
 
 
Medical and medication history 
X 
 
 
 
 
 
 
 
 
Physical examination 
X 
X b 
X 
X 
X 
 
X 
X 
X 
Vital signs c 
X 
X d 
X d 
X 
X 
 
X 
X 
X 
Electrocardiogram e 
X 
 
 
 
 
 
 
 
X 
ECOG performance status 
X 
 
 
 
 
 
 
 
X 
Clinical disease assessment   
 
X 
X 
X 
X 
 
X 
X 
X 
Concomitant medication 
X 
X 
X 
X 
X 
 
X 
X 
X f 
Adverse event recording 
X g 
X 
X 
X 
X 
 
X 
X 
X 
Treatments 
 
 
 
 
 
 
 
 
 
Dosing of ABP 798 / rituximab h 
 
X 
X 
X 
X 
 
X 
X 
 
Disease Assessments 
 
 
 
 
 
 
 
 
 
CT Scan  
X i 
 
 
 
 
 
X  
 
X j 
Bone marrow biopsy k 
X 
 
 
 
 
 
 
 
X k 
Laboratory Assessments 
 
 
 
 
 
 
 
 
 
Serology (HBsAg, HBcAb, HCV) 
X 
 
 
 
 
 
 
 
 
Serum chemistry l,m 
X 
X m 
X 
X 
X 
 
X 
X 
X 
Hematology m 
X 
X m 
X 
X 
X 
 
X 
X 
X 
Pregnancy n 
X 
 
 
 
 
 
 
 
 
PK sampling o,p,q 
 
X p 
X 
X 
X p 
X p 
X 
X 
X 
Pharmacodynamic (CD19+ cell 
count) q,r 
 
X 
X 
X 
X 
 
 
 
X 
Antidrug antibodies q,s 
 
X 
 
 
 
 
X 
X 
X 
IgG and IgM q 
 
X 
X 
X 
X 
 
 
 
X 

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CT = computed tomography; ECOG = Eastern Cooperative Oncology Group; HBcAb = hepatitis B core antibody; HBsAg = hepatitis B surface antigen; HCV = hepatitis 
C virus antibody; Ig = Immunoglobulin. 
(See footnotes below) 
 
a The first 12 randomized subjects will be observed for safety for 4 hours after the first administration of IP. 
b Includes weight and height within 8 days of visit 1. 
c Systolic blood pressure and diastolic blood pressure will be measured on the same arm (preferentially on the left arm) after the subject has been in a supine/sitting 
position for 5 minutes.   
d All subjects will be monitored for hypersensitivity reactions to IP by assessment of vital signs (systolic and diastolic blood pressure, pulse, respiration rate, and 
temperature) on visit 1 and visit 2 at the following time points: before IP infusion; approximately every 60 minutes during IP infusion; at the end of IP infusion; at 
approximately 60 minutes after the end of IP infusion.  Subjects with signs and symptoms of a hypersensitivity reaction to IP will have vital signs assessed and 
oxygen saturation monitored by pulse oximetry.   
e 12-lead electrocardiogram recordings will be obtained after the subject has been supine for 5 minutes. 
f Includes any additional treatment for NHL. 
g Only serious adverse events will be reported from signing of the informed consent until day 1. 
h The ABP 798/rituximab dose will be calculated based on the height and weight obtained within 8 days of visit 1.  ABP 798/rituximab dose to be administered after all 
assessments are completed for each visit.  If any scheduled dose of IP in the first 4 visits (ie, visit 1, visit 2, visit 3, and visit 4) is delayed from the scheduled visit date 
(by more than 3 days), then the dose will be administered as soon as possible and subsequent doses will be adjusted accordingly to remain once per week from the 
adjusted dose date.  See Section 8.5.6 for more details regarding dose adjustments, dose escalation, and stopping rules. 
i Subjects must have a baseline scan (CT of the neck [if palpable lymph node >1.0 cm]), chest, abdomen, and pelvis to assess disease burden within 6 weeks before 
randomization.  For subjects with contraindications to the contrast agent, the decision as to whether a non-contrast CT is used should be based on anatomic location 
of the disease and comparability with images previously taken in the course of the study.   
j End-of-study CT scan can be taken within 28 days prior to EOS visit.  Subjects who discontinue from the study due to disease progression should have a 
CT scan (as described in Section 9.6) prior to initiation of new anti-cancer treatment, if deemed clinically acceptable. 
k Subjects must have a bone marrow biopsy within 12 months before randomization.  Previously confirmed positive bone marrow involvement does not need to be 
repeated for purposes of screening.  An end-of-study biopsy is required if bone marrow involvement is identified at baseline for complete response (CR) 
confirmation.  If a confirmatory bone marrow assessment is not obtained, these subjects should be considered as only having a partial response (PR).  
l Clinical laboratory tests will be performed at local laboratories.  Additional and repeat laboratory safety testing may be performed at the discretion of the Investigator. 
m Serum chemistry and hematology for baseline (day 1) can be performed up to 3 days before baseline (day 1).  
n Serum or urine pregnancy tests for females of childbearing potential only at a local laboratory. 
o Pharmacokinetics samples will be collected at baseline on day 1/visit 1/week 1, predose at weeks 2, 3, 4, 12, and 20, and immediately after the end of infusion at 
week 12, and a single PK sample at week 28/EOS. 
p Subjects who agree to optional additional PK sampling will also be required to have PK samples collected at 2 hours (± 1 hour) postdose at week 1 and 
week 4 and at visit 4a (week 5)  
q Pharmacokinetics, pharmacodynamic, antidrug antibody and IgG and IgM samples will be sent to a central laboratory.  Details will be provided in a laboratory manual.   
r Pharmacodynamic CD19+ cell count will be analyzed at baseline on day 1/week 1 and at weeks 2 (day 8), 3, 4 and 28. 
s Antidrug antibodies will be analyzed by Amgen or a designee.  Sampling will be at baseline on day 1/week 1, prior to fifth dose at week 12, prior to the sixth dose at 
week 20 and at week 28/EOS.  Subjects with positive antidrug antibody results will be assessed for neutralizing antibodies.  Additional blood samples may be 
obtained to rule out antidrug antibodies. 
 

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8.6.1.1 
Efficacy Measurements 
The primary efficacy endpoint is the risk difference (RD) of ORR by week 28.  Response 
will be determined according to Cheson et al (1999).  
Secondary efficacy criteria include RD of ORR at week 12. 
8.6.1.2 
Pharmacokinetic/Pharmacodynamic Endpoints 
The PK endpoints will be the serum concentrations at predose and immediately after the 
end of the infusion at week 12.  Pharmacodynamic assessment includes percentage of 
subjects with complete depletion of CD19+ cell count from baseline to week 2 (day 8) 
and total IgG and IgM antibody levels. 
8.6.1.3 
Safety Measurements 
Safety endpoints include the following: 
 
treatment-emergent AEs and serious adverse events (SAEs) 
 
clinically significant changes in laboratory values and vital signs 
 
incidence of antidrug antibodies  
 
on study progression-free survival (PFS) 
 
on study overall survival (OS) 

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9 
STUDY EVALUATIONS BY VISIT 
After signing the informed consent, there are 8 planned visits, including a screening 
visit, a treatment visit on day 1 (day of first treatment; visit 1; week 1), treatment visits at 
visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 12), visit 6 (week 20), and 
an EOS visit at week 28.  Subjects who agree to optional additional PK sampling 
will be required to attend an additional visit (4a at week 5) as well as remain in the 
clinic for sampling 2 hours (± 1 hour) after infusion on visits 1 (day 1) and 4 
(week 4).  The first 12 subjects treated will remain at the clinic for 4 hours following the 
first (day 1) infusion for additional safety observation.   
9.1 
Screening 
Unless otherwise stated, the following assessments/procedures will be performed within 
28 days before randomization.  Assessments/procedures performed as routine standard 
of care, prior to the subject signing informed consent, and according to the criteria 
outlined in Section 10, can be used for screening purposes as long as the 
assessments/procedures were performed within 28 days before randomization (except 
for bone marrow biopsy and CT scan).  
 
informed consent form 
 
medical history, including history of NHL 
 
physical examination, including evaluation of body systems  
 
vital signs (systolic and diastolic blood pressure, pulse, respiration rate, and 
temperature)  
 
standard 12-lead electrocardiogram (ECG) 
 
ECOG performance status 
 
baseline CT of the neck (if palpable lymph node >1.0 cm), chest, abdomen, and 
pelvis within 6 weeks before randomization 
 
bone marrow biopsy within 12 months before randomization.  Previously 
confirmed positive bone marrow involvement does not need to be repeated for 
purposes of screening  
 
clinical laboratory testing, including serology, serum chemistry, and hematology 
 
serum or urine pregnancy test for women of childbearing potential 
At the screening assessment, all concomitant medications from 3 months before the 
planned start of study treatment will be recorded.  Any AEs occurring during the 
screening period will be recorded as medical history; any SAEs will be recorded using 
the eCRF.  SAEs will be reported as outlined in Section 11.2.2.  After screening but 
within 8 days before starting treatment, for eligible subjects the Investigator will contact 
the IXRS for randomization.  (Height and weight are required for IXRS randomization 
and must be collected within 8 days of visit 1). 

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9.1.1 
Screen Failures 
Subjects determined to be screen failures will not be eligible for immediate participation 
and must be registered as a screen failure in the IXRS.  Laboratory assessments used 
to determine subject eligibility may be repeated during the screening period before the 
subject is considered a screen failure.  Screen failed subjects may be re-screened up to 
2 times at the Investigator’s discretion (ie, total of 3 screens including initial screening).  
The subject will maintain the same subject identification number provided at the initial 
screening.  Subjects must be re-consented if more than 30 days have elapsed between 
date of initial informed consent and date of re-screen/randomization. 
9.2 
Baseline (Day 1, first day of administration of investigational product) 
Day 1 will be defined as the first day of administration of IP.  After subjects are confirmed 
to meet the entry criteria (Section 8.4), the Investigator (or designee) will contact the 
IXRS to randomize the subject centrally to receive blinded IP (ABP 798 or rituximab) 
within 8 days before the baseline visit.  The following assessments/procedures will be 
performed before treatment: 
 
physical examination, including evaluation of body systems and baseline height 
and weight; baseline height and weight will be measured within 8 days of 
visit 1 to allow use in randomization of subjects within 8 days of visit 1 
 
vital signs (systolic and diastolic blood pressure, pulse, respiration rate, and 
temperature) 
 
clinical disease assessment  
 
clinical laboratory testing, including serum chemistry and hematology (can be 
performed up to 3 days before baseline [day 1])  
 
collection of samples for pretreatment PK samples, pretreatment antidrug 
antibodies, pretreatment samples for CD19+ cell count, and IgG and IgM levels 
Any changes in concomitant medications since the last assessment will be recorded.  
Any pretreatment AEs will be recorded as medical history; any pretreatment SAEs will 
be recorded using the eCRF.  SAEs will be reported as outlined in Section 11.2.2. 
After completion of pretreatment procedures and premedications, ABP 798 or rituximab 
will be administered as an IV infusion in a double-blinded fashion.  The dose calculation 
for ABP 798 or rituximab will be based on the height and weight obtained within 8 days 
of visit 1.  Starting at the time of first treatment, all AEs, including increases in severity 
or frequency of pre-existing conditions, will be recorded in the eCRF.   
All subjects will be monitored for hypersensitivity reactions to IP by assessment of vital 
signs (systolic and diastolic blood pressure, pulse, respiration rate, and temperature) at 
the time points outlined in Section 8.5.1 (every 60 minutes during IP infusion, at the end 

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of the IV infusion, and approximately 60 minutes after the end of the IV infusion).  
Subjects who have agreed to additional optional PK sampling will have a 2 hour 
(± 1 hour) post dose PK sample collected.  Subjects with signs and symptoms of a 
hypersensitivity reaction to IP will have vital signs assessed and oxygen saturation 
monitored by pulse oximetry.    The first 12 subjects will be followed for 4 hours after the 
first (day 1) infusion for additional safety observation.  Subsequent subjects may leave 
the site after completion of the infusion and the 60 minute vital signs follow-up, according 
to local standard of care. 
Refer to Section 8.5.6 for IP infusion rate adjustments and stopping rules. 
9.3 
Visit 2 (Week 2), Visit 3 (Week 3), and Visit 4 (Week 4) 
At visit 2 (week 2 ± 3 days), visit 3 (week 3 ± 3 days), and visit 4 (week 4 ± 3 days), the 
subject will return to the study center for treatment.  The following 
assessments/procedures will be performed before treatment at each of these time 
points: 
 
vital signs (systolic and diastolic blood pressure, pulse, respiration rate, and 
temperature) 
 
physical examination and clinical disease assessment  
 
clinical laboratory testing, including serum chemistry and hematology  
 
collection of samples for pretreatment PK samples, pretreatment samples for 
CD19+ cell count, and IgG and IgM levels 
Any changes in concomitant medications since the last assessment will be recorded.  All 
AEs, including increases in severity or frequency of pre-existing conditions, will be 
recorded in the eCRF.  SAEs will be reported as outlined in Section 11.2.2. 
After completion of pretreatment procedures and premedications, ABP 798 or rituximab 
will be administered as an IV infusion in a double-blinded fashion.   
At visit 2, all subjects will be monitored for hypersensitivity reactions to IP by assessment 
of vital signs (systolic and diastolic blood pressure, pulse, respiration rate, and 
temperature) at the time points outlined in Section 8.5.1.   
For visit 3 and visit 4, subjects will be monitored during and after the infusion according 
to local standard of care and the approved product labeling.   
At visit 4, subjects who have agreed to additional optional PK sampling will have a 
2 hour (± 1 hour) post dose sample collected. 
Subjects with signs and symptoms of a hypersensitivity reaction to IP will have vital 
signs assessed and oxygen saturation monitored by pulse oximetry.   

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Refer to Section 8.5.6 for IP infusion rate adjustments and stopping rules. 
9.4 
Visit 4a (Week 5): Optional PK Sampling 
At visit 4a (week 5 ± 3 days) subjects who have agreed to additional optional PK 
sampling should return for PK sample collection.  No study treatment will be given 
at this visit. 
9.5 
Visit 5 (Week 12) and Visit 6 (Week 20) 
At visit 5 (week 12 ± 7 days) and visit 6 (week 20 ± 7 days), the subject will return to the 
study center for treatment.  The following assessments/procedures will be performed 
before treatment at each of these time points: 
 
vital signs (systolic and diastolic blood pressure, pulse, respiration rate, and 
temperature) 
 
physical examination and clinical disease assessment  
 
computed tomography (week 12 only) of the neck (if palpable lymph node 
> 1.0 cm or if performed at baseline), chest, abdomen, and pelvis  
 
clinical laboratory testing, including serum chemistry and hematology  
 
collection of pretreatment PK samples and pretreatment samples for antidrug 
antibodies  
Any changes in concomitant medications since the last assessment will be recorded.  All 
AEs, including increases in severity or frequency of pre-existing conditions, will be 
recorded in the eCRF.  SAEs will be reported as outlined in Section 11.2.2. 
After completion of pretreatment procedures and premedications, ABP 798 or rituximab 
will be administered as an IV infusion in a double-blinded fashion.   
Subjects will be monitored during and after the infusion according to local standard of 
care and the approved product labeling.   
Subjects with signs and symptoms of a hypersensitivity reaction to IP will have vital 
signs assessed and oxygen saturation monitored by pulse oximetry.   
Refer to Section 8.5.6 for IP infusion rate adjustments and stopping rules. 
The following procedure / assessment will be performed for all subjects after 
treatment on week 12 only: 
 
Immediately after completion of the infusion, postdose PK samples will be 
collected.  
 

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9.6 
Week 28/End of Study 
For subjects completing the treatment phase, the EOS visit will be at week 28, 8 weeks 
(± 7 days) after the last dose of IP.  For subjects who do not complete the treatment 
phase, the EOS visit will be 8 weeks (± 7 days) after the last dose of IP.  Subjects who 
discontinue from the study due to disease progression should have a CT scan (as 
described below) prior to initiation of new anti-cancer treatment, if deemed 
clinically acceptable. 
At the EOS visit (week 28 or 8 weeks after the last dose of IP), the following 
assessments will be performed:  
 
physical examination, including evaluation of body systems  
 
vital signs (systolic and diastolic blood pressure, pulse, respiration rate, and 
temperature) 
 
standard 12-lead ECG 
 
ECOG performance status 
 
clinical disease assessment  
 
CT (not required if performed within the previous 4 weeks) of the neck (if 
palpable lymph node >1.0 cm or if performed at baseline), chest, abdomen, and 
pelvis. 
 
bone marrow biopsy (only required if bone marrow involvement is identified at 
baseline for CR confirmation; if a confirmatory bone marrow assessment is 
not obtained, these subjects should be considered as only having a PR).  
The bone marrow biopsy can be performed at ± 14 days in relation to the 
study visit date.  
 
clinical laboratory testing, including serum chemistry and hematology 
 
collection of samples for PK, antidrug antibodies, CD19+ cell count, and IgG and 
IgM levels 
Any changes in concomitant medications since the last assessment will be recorded.  
Any additional treatment for lymphoma will be recorded.  All AEs, including increases in 
severity or frequency of pre-existing conditions, will be recorded in the eCRF through the 
week 28 visit.  SAEs will be reported as outlined in Section 11.2.2.  Any SAEs ongoing at 
week 28 will be followed until they resolve or are considered chronic or stable. 

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10 
METHODS OF ASSESSMENT 
10.1 Response Assessments 
Response to treatment will be assessed according to standardized criteria (Cheson et al, 
1999).  At the times indicated in Table 1, Investigators will assess the status of each 
subject's follicular B-cell NHL.  Assessment will include physical examination and 
radiographic examination.  Computed tomography scan is the preferred method for 
radiographic tumor assessment.  For subjects with contraindications to the contrast 
agent, the decision as to whether a non-contrast CT is used should be based on 
anatomic location of the disease and comparability with images previously taken in the 
course of the study. 
For radiographic assessments, the same method of assessment and the same 
technique (eg, scan type, scanner, subject position, dose of contrast, injection/scan 
interval) should be used to characterize each identified and reported lesion at baseline.  
However, if a subject is imaged without contrast at baseline, subsequent assessments 
should be performed with contrast, unless the subject cannot tolerate the contrast. 
Copies of all scheduled and unscheduled screening and on-study CT scans performed 
to monitor or diagnose NHL must be submitted to the central imaging vendor.  This 
includes any such images deemed to be negative by the local radiologist and any 
standard-of-care or routine disease monitoring images performed, even if not specified 
by the protocol.  Detailed procedures for image management will be provided in the 
study manual.  
Clinical disease assessments, which will be performed in conjunction with physical 
examinations, will be performed by the investigator or sub-investigator and will be 
submitted to the central imaging vendor, if applicable.  
Determination of response is outlined in Section 17.2. 
10.2 Pregnancy Test 
Pregnancy will be determined by evaluation of -human chorionic gonadotropin in serum 
or urine.  Subjects who are pregnant are excluded from the study. 
The Investigator will inform the Sponsor immediately of any case of pregnancy and 
collect information on any female subject who becomes pregnant while participating in 
this study and in case of pregnancy among female partners of male subjects.  The 
subject will also be followed to determine the outcome of the pregnancy. 

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10.3 Physical Examination  
Physical examinations will be performed by a physician and will include examination of 
the following:  general appearance, head, ears, eyes, nose, throat, neck, skin, 
cardiovascular system, respiratory system, abdominal system, and nervous system.  An 
assessment of normal or abnormal will be recorded.  Clinically relevant changes from 
baseline will be reported as AEs. 
Body weight (kg) will be measured without shoes or jacket.  Height and weight will be 
determined within 8 days of visit 1.  
10.4 Vital Signs  
Systolic blood pressure and diastolic blood pressure will be measured on the same arm 
(preferentially on the left arm) after the subject has been in a supine/sitting position for 
5 minutes.  Pulse will be recorded simultaneously with blood pressure measurements.  
Respiration rate and temperature will also be recorded. 
During the study, the measurement of vital signs may be repeated at the discretion of 
the Investigator for safety reasons.  Clinically relevant abnormal findings will be reported 
as AEs. 
All subjects will be monitored for hypersensitivity reactions to IP by assessment of vital 
signs (systolic and diastolic blood pressure, pulse, respiration rate, and temperature) at 
the following time points: 
 
before IP infusion on IP administration visit 1 and visit 2 
 
approximately every 60 minutes during IP infusion on IP administration visit 1 
and visit 2 
 
at the end of IP infusion on IP administration visit 1 and visit 2 
 
at approximately 60 minutes after the end of IP infusion on IP administration 
visit 1 and visit 2 
Subjects with signs and symptoms of a hypersensitivity reaction to IP will have vital 
signs assessed and oxygen saturation monitored by pulse oximetry.   
10.5 Electrocardiogram 
Computerized 12-lead ECG recordings will be obtained after the subject has been 
supine for 5 minutes.  Each lead will be recorded for at least 3 to 5 beats at a speed of 
25 mm/sec paper speed and 10 mm/mV amplitude.  At a minimum, heart rate, P, PR, 
QRS, QT, and corrected QT (QTc) intervals (msec) will be recorded from the 12-lead 
ECG.  A copy of the ECGs will be retained on site.  For the purposes of screening, the 

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Investigator or a designee will evaluate whether the ECG is normal or abnormal and 
whether it is clinically acceptable for inclusion, if abnormal.   
10.6 Clinical Laboratory Testing 
Venous blood samples will be taken for clinical laboratory tests at the time points 
indicated in Table 1.  The following parameters will be determined: 
Serology (local laboratory):  HBsAg, hepatitis B core antibody, and HCV antibody.  
Hematology (local laboratory):  Hemoglobin, packed cell volume, white blood cell 
count and ANC, platelet count. 
Clinical chemistry (local laboratory):  Sodium, potassium, urea, creatinine, total 
protein, albumin, total bilirubin, AST, ALT, alkaline phosphatase, LDH, non-fasting 
glucose, uric acid, beta-2-microglobulin (beta-2-microglobulin at screening only). 
Immunology (central laboratory):  Blood samples for antidrug antibody assessments 
will be collected at the time points indicated in Table 1. 
The above clinical laboratory tests will be performed at local laboratories, except 
immunology which will be sent to a central laboratory and analyzed by Amgen or a 
designee.  Further details of the procedures to be followed for sample collection, 
storage, and shipment will be documented in a Laboratory Manual. 
Samples testing positive for binding antibodies will also be tested for neutralizing 
antibodies and may be further characterized for quantity/titer, isotype, affinity, and 
presence of immune complexes.  Additional blood samples may be obtained to rule out 
antidrug antibodies.  Subjects who test positive for neutralizing antibodies to ABP 798 or 
rituximab at the final scheduled study visit may be asked to return for additional follow-up 
testing. 
The subjects with a neutralizing antibody at the end of the study may be followed if there 
are any clinical sequelae.  This testing may occur approximately every 3 months starting 
from when the site has been notified of the positive result, until: 
1. Neutralizing antibodies are no longer detectable OR 
2. The subject has been followed for a period of at least 1 year (± 4 weeks) 
post-administration of ABP 798 or rituximab. 
Additional and repeat laboratory safety testing may be performed at the discretion of the 
Investigator.  Any clinically relevant changes from baseline will be reported as AEs. 

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10.7 Blood Samples for Pharmacokinetic Analysis  
During treatment, a series of serum samples will be taken according to Table 1, and PK 
analyses will be performed by a central PK laboratory.  The exact times of blood 
sampling will be recorded.  
Details of the procedures to be followed for sample collection, storage, and shipment will 
be documented in the Laboratory Manual. 
10.8 Blood Samples for Pharmacodynamic Analysis 
Pharmacodynamic analyses will include CD19+ cell count and IgG and IgM levels and 
will be performed by a central laboratory.  Samples will be collected at the time points 
indicated in Table 1.   
Details of the procedures to be followed for sample collection, storage, and shipment will 
be documented in the Laboratory Manual. 

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11 SAFETY DATA COLLECTION, RECORDING, AND REPORTING 
11.1 Adverse Events 
11.1.1 
Definition of Adverse Events 
An AE is defined as any untoward medical occurrence in a clinical trial subject.  The 
event does not necessarily have a causal relationship with study treatment.  The 
Investigator is responsible for ensuring that any AEs observed by the Investigator or 
reported by the subject are recorded in the subject’s medical record as well as the 
eCRF.   
The definition of AEs includes worsening of a pre-existing medical condition.  Worsening 
indicates that the pre-existing medical condition (eg, diabetes, migraine headaches, 
gout) has increased in severity, frequency, and/or duration, and/or has an association 
with a significantly worse outcome.  In the case of worsening of a pre-existing condition, 
the start date of the event is the date when the first signs of worsening were observed.  
A pre-existing condition that has not worsened during the study or involves an 
intervention such as elective cosmetic surgery or a medical procedure while on study is 
not considered an AE.   
11.1.2 
Reporting Procedures for Adverse Events 
The Investigator is responsible for ensuring that all AEs observed by the Investigator or 
reported by the subject that occur from the day of randomization through the EOS visit 
are reported using the applicable eCRF Adverse Event Summary page.  AEs observed 
by the Investigator or reported by the subject that occur after signing of informed consent 
but before randomization will be recorded as medical history.  
The Investigator must assign the following AE attributes: 
 
AE diagnosis or syndrome(s), if known (if not known, signs or symptoms) 
 
dates of onset and resolution 
 
severity  
 
assessment of relatedness to IP 
 
action taken 
AEs must be graded for severity according to the CTCAE version 4.03 
(http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm).   
The Investigator must assess whether the AE is possibly related to the IP.  This 
relationship is indicated by a “yes” or “no” response to the question:  “Is there a 
reasonable possibility that the event may have been caused by the investigational 
product?” 

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Progression or recurrence of NHL should not be reported as an adverse event.  
However, any specific symptoms or sequelae of the disease progression or recurrence 
(eg, organ failure, respiratory distress, etc) will be considered adverse events and will be 
captured on the eCRF. 
The Investigator is responsible for reviewing laboratory test results and determining 
whether an abnormal value in an individual study subject represents a clinically 
significant change from the subject’s baseline values.  In general, abnormal laboratory 
findings without clinical significance (based on the Investigator's judgment) are not to be 
recorded as AEs.  However, laboratory value changes that require treatment or 
adjustment in current therapy are considered AEs.  Where applicable, clinical sequelae 
(not the laboratory abnormality) are to be recorded as the AE. 
The Investigator’s clinical judgment is used to determine whether a subject is to be 
removed from treatment due to an AE.  A subject, or subject’s legal guardian, can also 
voluntarily withdraw from treatment due to an AE.  If the subject withdraws consent, the 
subject is encouraged to undergo, at a minimum, an end-of-study assessment.   
11.2 Serious Adverse Events 
11.2.1 
Definition of Serious Adverse Events 
A SAE is defined as an AE that meets at least 1 of the following serious criteria: 
 
fatal 
 
life threatening (places the subject at immediate risk of death) 
 
requires inpatient hospitalization or prolongation of existing hospitalization 
 
results in persistent or significant disability/incapacity 
 
congenital anomaly/birth defect 
 
other medically important serious event 
An AE would meet the criterion of “requires hospitalization” if the event necessitated an 
admission to a health care facility (eg, overnight stay).   
If an Investigator considers an event to be clinically important, but it does not meet any 
of the serious criteria, the event could be classified as a SAE under the criterion of “other 
medically important serious event.”  Examples of such events could include allergic 
bronchospasm, convulsions, blood dyscrasias, drug-induced liver injury, or events that 
necessitate an emergency room visit, outpatient surgery, or urgent intervention. 

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11.2.2 
Reporting Procedures for Serious Adverse Events 
The Investigator is responsible for ensuring that all SAEs observed by the Investigator or 
reported by the subject that occur after signing of the ICF through the EOS visit are 
recorded in the subject’s medical record and are submitted to Amgen.   
The SAE must be submitted to Amgen, or its designee, within 24 hours following the 
Investigator’s knowledge of the event via the applicable eCRF.   
If the electronic data capture (EDC) system is not functional, the SAE can be reported by 
faxing a completed paper SAE Fax Cover Sheet and SAE report form or by direct 
telephone communication with PRA Safety Risk Management at the numbers provided 
below.  The event must be updated electronically in the EDC by the clinical site once the 
EDC function resumes. 
Fax information to Safety Risk Management/PRA, to the attention of:  
PRA Drug Safety Center 
For Europe, Asia, and Pacific Region Clinical Sites: 
FAX:  +44 1792 525 720 
Phone:  +49.621.8782.154 
MHGSafety@prahs.com 
 
For North America, Latin America, and South America Clinical Sites: 
FAX:  1.888.772.6919 
Phone:  1.800.772.2215 
CHOSafety@prahs.com 
New information relating to a previously reported SAE must be submitted to Amgen, or 
its designee.  All new information for SAEs must be sent to Amgen, or its designee, 
within 24 hours following knowledge of the new information.  The Investigator may be 
asked to provide additional follow-up information, which may include a discharge 
summary or extracts from the medical record.  Information provided about the SAE must 
be consistent with that recorded on the applicable eCRF (eg, AE Summary eCRF). 
Elective hospitalizations are not considered SAEs.  If a subject is permanently withdrawn 
from protocol-required therapies because of a SAE, this information must be submitted 
to Amgen, or its designee. 
To comply with worldwide reporting regulations for SAEs, the treatment assignment of 
subjects who develop serious, unexpected, and related AEs may be unblinded by 
Amgen, or its designee, before submission to regulatory authorities.  Investigators will 

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receive notification of related SAE reports sent to regulatory authorities in accordance 
with local requirements.   
Determination of expectedness for Amgen products will be based on the contents of the 
Investigator’s Brochure/Development Core Safety Information for IPs and the regional 
prescribing information for products being studied for an approved use.  Expectedness 
assessments are to be made for all IPs (Amgen and non-Amgen) using the appropriate 
reference safety information per local regulatory reporting requirements.  Suspected 
unexpected serious adverse reactions (SUSARs) reported for subjects receiving a non-
Amgen IP are to be expedited according to local requirements.  
Amgen, or its designee, reports SAEs and/or SUSARs as required to regulatory 
authorities, Investigators/institutions, and IRBs/IECs in compliance with all reporting 
requirements according to local regulations and GCPs.  
The Investigator is to notify the appropriate IRB/IEC of SAEs occurring at the site and of 
other AE reports received from Amgen, in accordance with local procedures and 
statutes. 
After the protocol-required reporting period defined above, the Investigator does not 
need to actively monitor subjects for SAEs.  However, if the Investigator becomes aware 
of a SAE after this protocol-required reporting period, the Investigator will report the 
event to Amgen within 24 hours following the Investigator’s knowledge of the event.  
SAEs reported outside of the protocol-required reporting period will be captured within 
the safety database as clinical trial cases for the purposes of expedited reporting.   
11.3 Events of Interest 
Events of interest (EOIs) for ABP 798/rituximab will be defined in the Statistical Analysis 
Plan (SAP) and analyzed from the clinical database.  There are no expedited reporting 
requirements for EOIs (other than those that meet other reporting requirements). 
11.4 Pregnancy Reporting 
Pregnancy in itself is not regarded as an AE unless there is a suspicion that an IP may 
have interfered with the effectiveness of a contraceptive medication.  All pregnancies 
with or without an adverse event will be collected and reported in the safety database.  
The outcome of all pregnancies (spontaneous miscarriage, elective termination, normal 
birth, or congenital abnormality) must be reported to Amgen, or its designee, and must 
be followed up and documented even if the subject was discontinued from the study. 

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All reports of congenital abnormalities/birth defects are SAEs.  Spontaneous 
miscarriages should also be reported and handled as SAEs.  Elective abortions without 
complications should not be handled as AEs.   
Pregnancies among female partners of male subjects will also be reported and followed 
for outcome. 

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12 
DATA MANAGEMENT AND STATISTICAL ANALYSIS 
The data management and statistical analysis of this study will be performed by PRA, an 
external clinical research organization (CRO). 
12.1 Data Management 
Previous and concomitant medications will be coded using the latest available World 
Health Organization (WHO) Drug Reference Dictionary.  Coexistent diseases and AEs 
will be coded using Medical Dictionary for Regulatory Activities (MedDRA). 
When the database has been declared to be complete and accurate, the database will 
be locked. 
12.2 Sample Size Estimation 
Approximately 250 subjects will be randomized in a 1:1 ratio to receive ABP 798 or 
rituximab.  
 
 
 
 
 
 
 
 
12.3 Statistical Analysis Plan 
A SAP will be written and finalized prior to any lock of the study database.  The SAP will 
provide a detailed description of the statistical methods and expand on the details 
provided in the protocol.  Additional analyses may be added.  Table, listing, and figure 
shells will also be included. 
12.4 Randomization 
Randomization will be performed by an IXRS.  The randomization schedule will be 
prepared by a statistician not involved in the conduct of the study.  Randomization will be 
stratified by geographic region and age (> 60 vs ≤ 60 years). 
12.5 Analysis Sets 
The primary analysis of the efficacy endpoints will be performed using the full analysis 
set (FAS).  The per-protocol analysis set will be used for sensitivity analyses of the key 

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efficacy endpoints.  The analysis of safety, pharmacokinetic and pharmacodynamic 
endpoints will be conducted on the safety analysis set. 
12.5.1 
Full Analysis Set 
The FAS includes all subjects randomized in the study.  
12.5.2 
Per-protocol Set 
The per-protocol analysis set is a subset of the FAS that includes subjects who have 
completed all 4 weekly IP doses or who permanently ended IP prior to completing 4 
weekly IP doses due to reasons allowed per protocol (ie, disease progression, adverse 
events and death), had at least one post-baseline tumor assessment, and did not 
experience a protocol deviation that would affect their evaluation for the primary 
objective of the study.  The protocol deviations that affect evaluation for the primary 
objective will be determined based on a blinded data review prior to database lock. 
12.5.3 
Safety Analysis Set 
The safety analysis set includes all randomized subjects who received at least 1 dose of 
IP.  
12.6 Statistical Methods 
Categorical variables will be summarized using the number and percentage of subjects 
falling into each category.  Continuous variables will be summarized using mean, 
standard error or standard deviation, median, minimum, maximum, and number of 
subjects with observations.  Kaplan-Meier estimates will be provided for time-to-event 
endpoints. 
12.6.1 
Missing Data 
Subjects without measurable disease at baseline and those without post-baseline 
disease assessments will be counted as nonresponders in the primary analysis.  
Additional imputation rules will be presented in the SAP before unblinding of the study 
for the primary analysis.   
12.6.2 
Demographic and Baseline Data 
The following demographics and baseline characteristics will be summarized:  age (in 
years, at time of signing informed consent), race, gender, ethnicity, height, and weight.  
Disease history and baseline disease characteristics will also be summarized. 
12.6.3 
Subject Disposition 
The following information will be summarized for subject disposition and accountability: 

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 
number of subjects randomized will be tabulated by country and site  
 
subject disposition (including number of subjects who were screened, 
randomized, treated with ABP 798/rituximab, completed study, and discontinued 
study early with reason for discontinuation) 
 
summaries of analysis populations with reason for exclusion 
 
important protocol deviations 
 
number and percentage of subjects on study at each visit  
 
randomization list of subjects and their actual versus randomized treatment 
group 
12.6.4 
Efficacy 
The primary efficacy hypothesis for this study is that there are no clinically meaningful 
differences between ABP 798 and rituximab in ORR by week 28.  Clinical equivalence 
will be demonstrated by first comparing the 1-sided 95% lower confidence interval (CI) 
limit of the RD of ORR by week 28 between ABP 798 and rituximab with a noninferiority 
margin of -15%.  If this is successful, the 1-sided 95% upper CI limit of the RD of ORR 
by week 28 between ABP 798 and rituximab will be compared with a nonsuperiority 
margin of +35.5%.  In addition, a 2-sided 95% CI will be calculated and evaluated 
against a symmetrical margin of 15% for noninferiority and nonsuperiority.  The CIs for 
RD will be estimated using a generalized linear model adjusted for the stratification 
factors.   
The primary analyses of ORR will be conducted based on central, independent, blinded 
radiologists’ assessments on the FAS according to randomized treatment.  The 
sensitivity analysis will be conducted based on central, independent, blinded radiologists’ 
assessments on the per-protocol analysis set according to actual treatment received and 
based on the Investigator’s assessment of disease on the FAS according to randomized 
treatment.  
Determination of response is outlined in Section 17.2. 
Inferential analyses will only be performed for the primary endpoint.  The secondary 
endpoints RD of ORR at week 12 will be summarized descriptively.   
12.6.5 
Pharmacokinetics 
The 90% CI for the geometric mean ratio (GMR) of test (ABP 798)-to-reference 
(rituximab) for serum concentrations at predose (trough) and immediately after the end 
of infusion at week 12 will be calculated.  Point estimates and CIs for the GMR will be 
estimated from an analysis of covariance model.  The analysis will be conducted on the 
safety analysis set according to actual treatment received.  Additional details on the PK 
analysis will be provided in the SAP. 

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12.6.6 
Pharmacodynamics 
Pharmacodynamic endpoints (complete depletion of CD19+ cell count from baseline to 
week 2 (day 8), total IgG and IgM antibody levels) will be summarized descriptively for 
the safety analysis set by actual treatment received. 
12.6.7 
Safety 
Safety will be assessed in the safety analysis set with treatment assignment based on 
actual treatment received.  Independent safety reviews will be performed by the DMC 
periodically throughout the study, including an initial safety review after the first 12 
subjects have received at least 2 doses of IP.  Blinded study data will also be monitored 
on an ongoing basis by the blinded clinical study team to ensure subjects’ safety.  Safety 
analysis will include analyses of drug exposure, AEs, PFS and OS, clinical laboratory 
tests, vital signs, ECGs, and antidrug antibodies. 
12.6.7.1 
Investigational Product Administration 
For the IP (ABP 798 or rituximab), summary statistics will be provided for the total 
number of doses and total duration of IP exposure throughout the study.   
12.6.7.2 
Adverse Events 
All verbatim terms for any reported AEs will be coded to the appropriate system organ 
class and preferred term according to the current version of the MedDRA dictionary, and 
graded by the Investigator for severity as per CTCAE version 4.03.  The number and 
percentage of subjects reporting AEs (all, serious, treatment related, and deaths) will be 
reported.  
Only treatment-emergent AEs will be summarized.  Treatment-emergent events are 
those that begin or increase in severity or frequency at or after the time of first treatment 
up to the EOS visit.  All treatment-emergent AEs will be summarized by treatment arm 
and according to the MedDRA system organ class (SOC) and preferred term.  
Summaries will be provided for the incidence of all treatment-emergent AEs by severity.  
Additional summaries will be presented for SAEs.  All AE data will be listed by subject, 
and a separate listing will include all SAEs, including any deaths on study. 
Adverse events of interest (Section 11.3) will be summarized by treatment arm and 
preferred term.   
12.6.7.3 
Immunogenicity 
The number and percentage of subjects developing antidrug antibodies and those 
developing neutralizing antibodies will be tabulated for each treatment. 

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12.6.7.4 
Progression-free Survival and Overall Survival 
Progression-free survival is defined as the time from randomization until the first 
occurrence of disease progression or death from any cause according to the standard 
criteria in Cheson et al, 1999.  For subjects alive and progression-free at the week 
28/EOS visit, PFS will be censored at the date of the last tumor evaluation 
demonstrating lack of progression.   
Overall survival is defined as the time from randomization to death from any cause.  
Subjects who have not died before the week 28/EOS visit will be censored for OS at the 
last known date alive on or prior to EOS.  
For these time-to-event outcomes, the hazard ratio and 1-sided 95% and 97.5% CIs for 
ABP 798 relative to rituximab will be estimated from a Cox model stratified by 
stratification factors.  In addition, Kaplan-Meier curves and median survival time will be 
provided descriptively. 
12.6.7.5 
Concomitant Medications and Therapies 
Concomitant medications will be coded by WHO Drug Dictionary and will be summarized 
by treatment group with number and percentage of subjects receiving each category of 
medication. 
12.6.7.6 
Clinical Laboratory Test 
Clinical laboratory test results and change from baseline will be summarized by time 
point.  In addition, shift tables, from baseline to the worst on-study laboratory toxicity 
based on CTCAE v4.03 grading, will be presented. 
12.6.7.7 
Vital Signs and Physical Examinations 
Vital sign data (observed and change from baseline) will be summarized using 
descriptive statistics by time point and treatment.  Abnormal findings from physical 
examinations will be listed by subject and assessed for clinical significance and included 
in the AE listings and summaries. 
12.6.7.8 
Electrocardiograms 
Electrocardiogram results will be summarized using descriptive statistics.   
12.6.8 
Interim Analysis 
A safety analysis will be performed by a DMC (Section 12.6.9) after the first 12 subjects 
have received at least 2 doses of IP.   
No interim analyses of efficacy or pharmacodynamics are planned. 

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12.6.9 
Data Monitoring Committee 
A DMC external to Amgen and PRA will be formed with members consisting of 
individuals chosen for their expertise in follicular NHL.  Members of the DMC will include, 
at a minimum, physicians external to Amgen and PRA, and appropriate statistical 
representation external to Amgen and PRA.  The primary role of this independent DMC 
will be to monitor safety data.  
The DMC will review unblinded safety data at regular intervals, as outlined in the DMC 
charter (approximately twice yearly; the first assessment will be when 12 subjects have 
received at least 2 doses of IP).  
The DMC will communicate major safety concerns and recommendations regarding 
study modification or termination to Amgen management at any time during the conduct 
of the study.  
Records of all meetings will be archived.  Selected Amgen, or its designee, staff may 
serve as liaisons to the external DMC, but will not be voting members and will not be 
unblinded to the results.  Details regarding the DMC will be provided in the DMC charter. 

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13 
MONITORING PROCEDURES (QUALITY ASSURANCE) 
Amgen has ethical, legal, and scientific obligations to conduct this study in accordance 
with established research principles and ICH GCP guidelines.  As such, in order to fulfill 
these obligations and to maintain current of study progress, Amgen monitors, or 
Amgen’s designees, will visit the investigative sites during study conduct, in addition to 
maintaining telephone and written communication.  On-site visits, telephone calls, and 
regular inspection of the eCRFs will be conducted in order to assess subject enrollment, 
compliance with protocol procedures, completeness and accuracy of data entered on the 
eCRFs, verification of eCRF data against original source documents, and occurrence of 
AEs.  The Investigator must provide the monitor with full access to all source and study 
documents. 
13.1 Routine Monitoring 
Amgen, or its designee, assigned monitors will conduct regular site visits to the 
investigational facilities for the purpose of monitoring various aspects of the study.  The 
Investigator must agree to Amgen, or its designee, authorized personnel having direct 
access to the clinical (or associated) files and clinical study supplies (dispensing and 
storage areas) for all study subjects considered for study entry for the purpose of 
verifying entries made in the eCRF, and must assist with their activities, if requested.  
Adequate time and space for monitoring visits should be made available by the 
Investigator. 
The site must complete the eCRFs in a timely manner and on an ongoing basis to allow 
regular review by the study monitor. 
Whenever a subject name is revealed on a document that is to be collected for the 
Sponsor the name must be blacked out permanently by the site personnel, leaving the 
initials visible, and must be annotated with the subject number as identification. 
13.2 Inspections and Auditing Procedures 
Amgen, or its designee, may conduct audits at the investigative sites including, but not 
limited to, drug supply, presence of required documents, the informed consent process, 
and comparison of eCRFs with source documents.  All medical records (progress notes) 
must be available for audit.  The Investigator agrees to participate with audits conducted 
at a convenient time in a reasonable manner. 
Government regulatory authorities may also inspect the Investigator during or after the 
study.  The Investigator or designee should contact Amgen, or its designee, immediately 

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if this occurs.  He/she must cooperate fully with regulatory authorities or other audits 
conducted at a convenient time in a reasonable manner. 
The purpose of an audit is to assess whether ethics, regulatory and quality requirements 
are fulfilled. 

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14 
STUDY MANAGEMENT AND MATERIALS 
14.1 Electronic Case Report Forms 
An eCRF will be used to store and transmit subject information.  The file structure and 
format for the eCRF will be provided by the Sponsor or their representative and should 
be handled in accordance with the instructions provided. 
The eCRF must be reviewed and electronically signed, and dated by the Investigator. 
Access to the eCRF will be strictly password protected and limited to personnel directly 
participating in the study.  Complete data should be entered into the eCRF by examining 
personnel or the appropriate site staff.  The eCRF must be completed as soon as 
possible after any subject evaluation or communication.  If data are to be changed due 
to erroneous input or other reason, an electronic audit trail will track these changes.  The 
eCRFs and computers that store them must be accessible to study monitors and other 
regulatory auditors. 
14.2 Data Collection 
During each study visit, a physician participating in the study will maintain progress 
notes in the subject’s medical records to document all significant observations.  At a 
minimum, these notes will contain: 
 
the date of the visit and the corresponding day or visit in the study schedule (eg, 
screening, day 1, and week 2) 
 
general condition and status remarks by the subject, including any significant 
medical findings.  The severity, frequency, duration, and resolution of any 
reported AE, and the Investigator's assessment as to whether or not the 
reported AE is study drug-related 
 
changes in concomitant medications or dosages. 
 
a general reference to the procedures completed 
 
the signature or initials of all physicians making an entry in the medical record 
(progress notes) 
In addition, any contact with the subject via telephone or other means that provides 
significant clinical information will also be documented in the medical record (progress 
notes), as described above.  
Information from the medical records (progress notes) and other source documents will 
be promptly transcribed to the appropriate section of the eCRF. 
Changes to information in the medical record (progress notes), eCRF, and other source 
documents will be initialed and dated on the day the change is made by the Investigator 

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or designee.  If the reason for the change is not apparent, a brief explanation for the 
change will be written adjacent to the change. 
14.3 Source Documents Maintenance 
Source documents contain the results of original observations and activities of a clinical 
investigation.  Source documents include, but are not limited to, medical records 
(progress notes), computer printouts, screening logs, and recorded data from automated 
instruments.  
All source documents from this study will be maintained by the Investigator and made 
available for inspection by authorized persons.  The original signed informed consent for 
each subject shall be filed with records kept by the Investigator and a copy shall be 
given to the subject. 
14.4 Record Maintenance 
All data derived from the study will remain the property of Amgen Inc. 
Records must be retained in accordance with the current ICH Guidelines on GCP.  All 
essential study documents including records of subjects, source documents, eCRFs and 
study drug inventory must be kept on file. 
Essential documents should be retained until at least 2 years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region, or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the IPs.  However, essential documents 
may be retained for a longer period if required by the applicable regulatory requirements 
or by agreement with the Sponsor.   
The Investigator will not dispose of any records relevant to this study without written 
permission from the Sponsor, and will give the Sponsor the opportunity to collect such 
records.  The Investigator shall take responsibility for maintaining adequate and accurate 
hard copy source documents of all observations and data generated during this study.  
Such documentation is subject to inspection by the Sponsor, its representatives, and 
regulatory authorities. 
If an Investigator moves, withdraws from an investigation, or retires, the responsibility for 
maintaining the records may be transferred to another person who will accept 
responsibility.  Notice of transfer must be made to and agreed by the Sponsor. 

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14.5 Confidentiality 
All information obtained during the conduct of the study with respect to the subject’s 
state of health will be regarded as confidential.  For disclosure of any such information, 
an agreement will be obtained in writing.  
The Investigator must ensure that each subject’s anonymity is maintained.  On eCRFs 
and other documents submitted to the Sponsor or the CRO, subjects must not be 
identified by name.  Instead, subjects will only be known by the unique subject number 
allocated to them in order to ensure confidentiality on all study documentation.  Subjects 
will retain this unique number throughout the study.  The Investigator will keep a 
separate log of these codes. 
In order to comply with government regulatory guidelines and to ensure subject safety, it 
may be necessary for the Sponsor and its representative, the CRO personnel, the local 
research review board, or the US FDA to review subjects’ medical records as they relate 
to this study.  Only the subject’s unique number on the eCRFs will identify him/her, but 
his/her full name may be made known to a drug regulatory authority or other authorized 
government or health care officials, if necessary, and to personnel designated by the 
Sponsor. 
Documents that are not for submission to the Sponsor or the CRO (eg, consent forms) 
will be maintained by the Investigator in strict confidence, except to the extent necessary 
to allow monitoring by the Sponsor and the CRO, and auditing by regulatory authorities.  
No documents identifying subjects by name will leave the investigative site and subject 
identity will remain confidential in all publications related to the study. 

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15 
ADMINISTRATION PROCEDURES 
15.1 Regulatory Approval 
Amgen Inc., or their appointed agents, will be responsible for ensuring that appropriate 
regulatory authority approvals are obtained, according to local country requirements. 
No subject may enter the study until this approval has been obtained.  A copy of the 
approval (where one is provided as requested, according to local country requirements) 
will be provided to the Investigator and to the IRB(s)/IEC(s). 
15.2 Protocol Amendments 
In accordance with ICH Topic E 6 (R1) Guideline for GCP the Investigator should not 
implement any deviation from or changes to the protocol without agreement by the 
Sponsor and documented approval from the IRB/IECs of a protocol amendment, except 
where necessary to eliminate an immediate hazard(s) to study subjects, or when the 
change(s) involves only logistical or administrative aspects of the study (eg, change in 
monitor[s], change of telephone number[s]).  
Any change to the protocol must be handled as a protocol amendment.  Any potential 
amendment must be approved by the Sponsor.  A written amendment must be 
submitted to the appropriate regulatory authorities and to the IRB/IECs assuming this 
responsibility.  The Investigator must await IRB/IEC approval of protocol amendments 
before implementing the changes, except where necessary to eliminate apparent 
immediate hazard to subjects.  In these cases, the IRB/IEC must be notified within 
5 days of the change. 
All amendments to the protocol must be approved in writing by both the appropriate 
regulatory authorities and the IRB/IEC, except for administrative amendments, which 
require notification but not written approval.  Once approved, the protocol amendment 
will be distributed to all recipients of the original protocol, with instructions to append the 
amendment to the protocol. 
If, in the judgment of the local IRB/IEC, the Investigator and/or Sponsor, the protocol 
amendment alters the study design, procedures and/or increases the potential risk to the 
subject, the currently approved written ICF will require modification.  The modified ICF 
must also be reviewed and approved by the Sponsor, appropriate regulatory authorities, 
and the IRB/IEC.  In such cases, repeat informed consent must be obtained from 
subjects enrolled in the study before participation continues. 

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15.3 Protocol Adherence and Deviations 
The protocol must be read thoroughly and the instructions must be followed.  However, 
exceptions will be made in emergency situations when the protection, safety, and 
well-being of the subject requires immediate intervention based on the judgment of the 
Investigator or a responsible, appropriately trained, and credentialed professional(s) 
designated by the Investigator as a sub-investigator.  
In the event of a significant protocol deviation due to an emergency, accident, or error, 
the Investigator or designee must contact the Medical Monitor at the earliest possible 
time by telephone.  This allows for an early joint decision to be made as to whether or 
not the subject should continue in the study.  The Investigator, the Sponsor, and the 
Medical Monitor will document this decision. 
15.4 Publication Policy 
Authorship of any publications resulting from this study will be determined on the basis 
of the Uniform Requirement for Manuscripts Submitted to Biomedical Journals 
(International Committee of Medical Journal Editors), which states: 
 
Authorship credit is to be based on (1) substantial contributions to conception 
and design, acquisition of data, or analysis and interpretation of data; (2) drafting 
the article or revising it critically for important intellectual content; (3) final 
approval of the version to be published; 4) agreement to be accountable for all 
aspects of the work in ensuring that questions related to the accuracy or integrity 
of any part of the work are appropriately investigated and resolved.  Authors are 
to meet conditions 1, 2, 3, and 4. 
 
When a large, multicenter group has conducted the work, the group is to identify 
the individuals who accept direct responsibility for the manuscript.  These 
individuals are to fully meet the criteria for authorship defined above. 
 
Acquisition of funding, collection of data, or general supervision of the research 
group, alone, does not justify authorship. 
 
All persons designated as authors are to qualify for authorship, and all those 
who qualify are to be listed. 
 
Each author is to have participated sufficiently in the work to take public 
responsibility for appropriate portions of the content. 
All publications (eg, manuscripts, abstracts, oral/slide presentations, book chapters) 
based on this study must be submitted to Amgen for review.  The Clinical Trial 
Agreement between the institution, Investigator, and Amgen will detail the procedures 
for, and timing of, Amgen’s review of publications. 

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15.5 Clinical Study Report 
A final clinical study report will be prepared according to the ICH guideline on Structure 
and Contents of Clinical Study Reports.  A final clinical study report will be prepared 
regardless of whether the study is completed or prematurely terminated.    
15.6 Contractual and Financial Details 
The Investigator (and/or, as appropriate, the hospital administrative representative) and 
Amgen, or its designee, will sign a clinical study agreement prior to the start of the study, 
outlining overall Amgen, or its designee, and Investigator responsibilities in relation to 
the study.  Financial Disclosure Statements will be completed only as required by local 
regulations. 
15.7 Compensation 
Any arrangements for compensation to subjects for injury or illness that arises in the 
study are described in the Compensation for Injury section of the Informed Consent that 
is available as a separate document. 
15.8 Discontinuation of the Study 
This study may be terminated by Amgen at any time.  In terminating the study, Amgen, 
the CRO (PRA) and the Investigator will ensure that adequate consideration is given to 
the protection of the subjects’ interests.  Amgen will not provide ABP 798 or rituximab 
after termination of the trial or upon discontinuation of the study for the subject. 
15.9 Study Center File Management 
The Investigator is responsible for assuring that the Study Center File is maintained.  
The Study Center File will contain, but will not be limited to, the information listed below: 
1. Investigator’s Brochure 
2. Current, signed version of the protocol and any previous versions of the protocol 
3. Protocol amendments (if applicable) 
4. Operations Manual (if applicable) 
5. Current ICF (blank) and any previous versions of the ICF 
6. Curricula Vitae of Investigator(s) and sub-investigator(s) and photocopy of their 
respective license(s) where required by law; Original US FDA Form 1572 (for all 
studies conducted under US Investigational New Drug regulations), signed by all 
Principal Investigators.  The names of any sub-investigators must appear on this 
form.  Investigators must also complete all regulatory documentation as required the 
ICH GCP and by local or national regulations 
7. Documentation of IRB/IEC approval of the protocol, the ICF, any protocol 
amendments, and any ICF revisions 
8. All correspondence between the Investigator, IRB/IEC, and the Sponsor/CRO 
relating to study conduct 

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9. Lab certification(s) 
10. Monitoring log 
11. Study drug invoices 
12. Signature list of all staff completing eCRFs 
13. Signature list of all staff completing drug accountability summaries 

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16 
REFERENCE LIST 
Advani R, Rosenberg SA, Horning SJ. Stage I and II Follicular Non-Hodgkin’s 
lymphoma: Long-term follow-up of no initial therapy. J Clin Oncol. 2004;22:1454-1459. 
American Cancer Society.  Cancer Facts and Figures 2013.  Atlanta: American Cancer 
Society; 2013. 
Ardeshna KM, Qian W, Smith P, et al. Rituximab versus a watch-and-wait approach in 
patients with advanced-stage, asymptomatic, non-bulky follicular lymphoma: an open-
label randomised phase 3 trial. Lancet Oncol. 2014;15(4):424-435.  
Ardeshna KM, Smith P, Norton A, et al. Long-term effect of a watch and wait policy 
versus immediate systemic treatment for asymptomatic advanced stage non-Hodgkin 
lymphoma: A randomised controlled trial. Lancet. 2003;362:516–522. 
Ardeshna K, Smith P, Qian W, et al. An intergroup randomised trial of rituximab versus a 
watch and wait strategy in patients with stage II, III, IV, asymptomatic, non-bulky 
follicular lymphoma (Grades 1, 2 and 3a). A preliminary analysis. Blood. 
2010;116:abstract 6. 
Armitage, JO. Staging non-Hodgkin lymphoma. CA Cancer J Clin. 2005;55:368-376. 
Chen Q, Ayer T, Nastoupil LJ, et al.  Initial management strategies for follicular 
lymphoma.  Int J Hematol Oncol. 2012 October; 1(1):35–45. 
Cheson BD, Horning SJ, Coiffier B, Shipp MA, et al.  Report of an international workshop 
to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored 
International Working Group.  J Clin Oncol. 1999;17(4):1244.  Erratum in: J Clin Oncol. 
2000;18(11):2351. 
CHMP/437/04.  Guideline on similar biological medicinal products.  Rev 1(draft). 
EMEA/CHMP/BWP/247713/2012.  Guideline on similar biological medicinal products 
containing biotechnology-derived proteins as active substance:  quality issues (Rev1) 
(draft).  
EMEA/CHMP/BMWP/42832/2005 Rev.1.(draft).  Guideline on similar biological 
medicinal products containing Biotechnology-derived proteins as active substance:  Non-
clinical and clinical issues.   
EMA/CHMP/BMWP/403543/2010. Guideline on similar biological medicinal products 
containing monocolonal antibodies – non-clinical and clinical issues. 

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Ferlay J, Parkin DM, Steliarova-Foucher E. Estimates of cancer incidence and mortality 
in Europe in 2008. Eur J Cancer. 2010 Mar;46(4):765-81. 
Friedberg J, Huang J, Dillon H, et al. Initial therapeutic strategy in follicular lymphoma: 
An analysis from the National LymphoCare Study. J Clin Oncol. 2006;24:428s. 
Friedberg JW, Mauch PM, Rimsza LM, Fisher RI. Non-Hodgkin's lymphomas. In: DeVita 
VT, Lawrence TS, Rosenberg SA (eds). Cancer: Principles & Practice of Oncology. 
2008. Lippincott Williams & Wilkins, Philadelphia. 
Herold M, Haas A, Srock S, et al. Rituximab added to first-line mitoxantrone, 
chlorambucil, and prednisolone chemotherapy followed by interferon maintenance 
prolongs survival in patients with advanced follicular lymphoma: An East German Study 
Group Hematology and Oncology Study. J Clin Oncol. 2007;25:1986–1992. 
Morton LM, Wang SS, Devesa SS, Hartge P, Weisenburger DD, Linet MS. Lymphoma 
incidence patterns by WHO subtype in the United States, 1992-2001. Blood. 2006 Jan 1; 
107(1):265-76. 
Pileri SA, Zinzani PL, Went P, Pileri A Jr, Bendandi M. Indolent lymphoma: the 
pathologist's viewpoint. Ann Oncol. 2004 Jan; 15(1): 12-8. 
Schmatz AI, Streubel B, Kretschmer-Chott E, et al. Primary follicular lymphoma of the 
duodenum is a distinct mucosal/submucosal variant of follicular lymphoma: A 
retrospective study of 63 cases. J Clin Oncol. 2011;29:1445–1451. 
Solal-Celigny P, Lepage E, Brousse N, et al. Doxorubicin containing regimen with or 
without interferon alfa 2b for advanced follicular lymphomas: final analysis of survival 
and toxicity in the Groupe d’Etude des Lymphomes Folliculaire 86 trial. J Clin Oncol. 
1998;16:2332-2338. 
Swerdlow SH, Campo E, Harris NL, Jaffe ES, Pileri SA, Stein H, Thiele J Vardiman JW.  
WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues (ed 4th). 
Lyon, France. IARC Press. 2008. 
US FDA.  Guidance for Industry:  Scientific considerations in demonstrating biosimilarity 
to a reference product.  February 2012a, US FDA (draft). 
US FDA.  Guidance for Industry:  Quality considerations in demonstrating biosimilarity to 
a reference protein product.  February 2012b, US FDA (draft). 
WHO Classification of tumours of haematopoietic and lymphoid tissues.  IARC 2008. 

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17 APPENDICES 
17.1 Appendix 1: Elements of Informed Consent 
ELEMENTS OF INFORMED CONSENT 
Both the informed consent discussion and the written informed consent form (ICF) and 
any other written information to be provided to subjects should include explanations of the 
following: 
 
That the study involves research. 
 
The purpose of the study. 
 
The study treatment(s) and the probability for random assignment to each 
treatment. 
 
The study procedures to be followed including all invasive procedures. 
 
The subject’s responsibilities. 
 
Those aspects of the study that are experimental. 
 
The reasonably foreseeable risks or inconveniences to the subject and, when 
applicable, to an embryo, fetus, or nursing infant. 
 
The reasonably expected benefits.  When there is no intended clinical benefit to 
the subject, the subject should be made aware of this. 
 
The alternative procedure(s) or course(s) of treatment that may be available to 
the subject, and their important potential benefits and risks. 
 
The compensation and/or treatment available to the subject in the event of 
study-related injury. 
 
The anticipated prorated payment, if any, to the subject for participating in the 
study. 
 
The anticipated expenses, if any, to the subject for participating in the study. 
 
That the subject’s participation in the study is voluntary and that the subject may 
refuse to participate or withdraw from the study, at any time, without penalty or 
loss of benefits to which the subject is otherwise entitled. 
 
That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) 
will be granted direct access to the subject’s original medical records for 
verification of clinical study procedures and/or data, without violating the 
confidentiality of the subject, to the extent permitted by the applicable laws and 
regulations and that, by signing a written ICF, the subject or the subject’s legally 
acceptable representative is authorizing such access. 
 
That records identifying the subject will be kept confidential and, to the extent 
permitted by the applicable laws and/or regulations, will not be made publicly 
available.  If the results of the study are published, the subject’s identity will 
remain confidential. 
 
That the subject or the subject’s legally acceptable representative will be 
informed in a timely manner if information becomes available that may be 
relevant to the subject’s willingness to continue participation in the study. 
 
The person(s) to contact for further information regarding the study and the 
rights of study subjects, and whom to contact in the event of study-related injury. 
 
The foreseeable circumstances and/or reasons under which the subject’s 
participation in the study may be terminated. 
 
The expected duration of the subject’s participation in the study. 
 
The approximate number of subjects involved in the study. 
 
 

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17.2 Appendix 2: Response Determination by IWG (1999) Criteria 
Responses will be categorized as CR, partial response (PR), stable disease (SD), or 
progressive disease (PD).  In addition, a response category of not evaluable (NE) is 
provided for situations in which there is inadequate information to otherwise categorize 
response status.   
17.2.1.1 
Complete Response 
To satisfy criteria for CR, all of the following criteria must be met: 
1. Complete disappearance of all detectable clinical and radiographic evidence of 
disease and disappearance of all disease-related symptoms if present before 
therapy, and normalization of those biochemical abnormalities (eg, lactate 
dehydrogenase) definitely assignable to NHL. 
2. All lymph nodes and nodal masses must have regressed to normal size 
(≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm before 
therapy).  Previously involved nodes that were 1.1 to 1.5 cm in their greatest 
transverse diameter before treatment must have decreased to ≤ 1 cm in their 
greatest transverse diameter after treatment, or by more than 75% in the sum of 
the products of the greatest diameters (SPD). 
3. The spleen, if considered to be enlarged before therapy on the basis of a CT 
scan, must have regressed in size and must not be palpable on physical 
examination.  However, no normal size can be specified because of the 
difficulties in accurately evaluating splenic and hepatic size.  For instance, 
spleens thought to be of normal size may contain lymphoma, whereas an 
enlarged spleen may not necessarily reflect the presence of lymphoma but 
variations in anatomy, blood volume, the use of hematopoietic growth factors, or 
other causes.  Any macroscopic nodules in any organs detectable on imaging 
techniques should no longer be present.  Similarly, other organs considered to 
be enlarged before therapy due to involvement by lymphoma, such as liver and 
kidneys, must have decreased in size. 
4. If the bone marrow was involved by lymphoma before treatment, the infiltrate 
must be cleared on repeat bone marrow aspirate and biopsy of the same site.  
The sample on which this determination is made must be adequate (≥ 20 mm 
biopsy core).  
17.2.1.2 
CR/unconfirmed 
CR/unconfirmed (CRu) includes those patients who fulfill criteria 1 and 3 above, but with 
one or more of the following features: 
1. A residual lymph node mass greater than 1.5 cm in greatest transverse diameter 
that has regressed by more than 75% in the SPD.  Individual nodes that were 
previously confluent must have regressed by more than 75% in their SPD 
compared with the size of the original mass.  
2. Indeterminate bone marrow (increased number or size of aggregates without 
cytologic or architectural atypia). 
17.2.1.3 
Partial Response 
PR requires the following: 

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1. ≥ 50% decrease in SPD of the six largest dominant nodes or nodal masses. 
These nodes or masses should be selected according to the following features: 
• 
(a) they should be clearly measurable in at least two perpendicular 
dimensions, 
• 
(b) they should be from as disparate regions of the body as possible, and 
• 
(c) they should include mediastinal and retroperitoneal areas of disease 
whenever these sites are involved.  
2. No increase in the size of the other nodes, liver, or spleen.  
3. Splenic and hepatic nodules must regress by at least 50% in the SPD.  
4. With the exception of splenic and hepatic nodules, involvement of other organs 
is considered assessable and not measurable disease.  
5. Bone marrow assessment is irrelevant for determination of a PR because it is 
assessable and not measurable disease; however, if positive, the cell type 
should be specified in the report, eg, large-cell lymphoma or low-grade 
lymphoma (ie, small, lymphocytic small cleaved, or mixed small and large cells).  
6. No new sites of disease. 
17.2.1.4 
Stable Disease 
Stable disease is defined as less than a PR (see above) but is not progressive disease 
(see below). 
17.2.1.5 
Relapsed Disease 
Relapsed disease (CR, CRu) requires the following: 
1. Appearance of any new lesion or increase by ≥ 50% in the size of previously 
involved sites. 
2. ≥ 50% increase in greatest diameter of any previously identified node greater 
than 1 cm in its short axis or in the SPD of more than one node. 
17.2.1.6 
Progressive Disease 
Progressive disease (PR, nonresponders) requires the following: 
1. ≥ 50% increase from nadir in the SPD of any previously identified abnormal 
node for PRs or nonresponders. 
2. Appearance of any new lesion during or at the end of therapy 
 
 
Cheson BD, Horning SJ, Coiffier B, Shipp MA, et al. Report of an international workshop 
to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored 
International Working Group. J Clin Oncol 1999;17(4):1244. Erratum in: J Clin Oncol. 
2000;18(11):2351. 
 
.

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17.3 Appendix 3: Cotswold Modification of Ann Arbor Staging System  
Stage 
Description 
Stage I 
Involvement of a single lymph node region or lymphoid structure (eg, spleen, 
thymus, Waldeyer’s ring) or involvement of a single extralymphatic (E) site 
(Stage IE) 
Stage II 
Involvement of two or more lymph node regions on the same site of the 
diaphragm (II) or localized contiguous involvement of only one extranodal 
organ or side and its regional lymph nodes with or without other lymph node 
regions on the same side of the diaphragm (Stage IIE) 
Note: the number of anatomic regions involved may be indicated by a 
subscript (eg,Stage II3) 
Stage III 
Involvement of lymph node regions on both sides of the diaphragm (Stage III), 
which also may be accompanied by involvement of the spleen (Stage IIIS) or 
by localized contiguous involvement of only one extranodal organ side (Stage 
IIIE) or both (Stage IIISE) 
Stage IV 
Disseminated (multifocal) involvement of one or more extranodal organs or 
tissues, with or without associated lymph node involvement or isolated 
extralymphatic organ involvement with distant (nonregional) nodal involvement 
Designations applicable to any disease stage 
 
A: No symptoms 
 
B: Fever (temperature > 38°C, night sweats, unexplained loss of more than 10% 
body weight during the previous 6 months) 
 
X: Bulky disease 
 
E: Involvement of a single extranodal site that is contiguous or proximal to the 
known nodal site 
Armitage, JO. Staging non-Hodgkin lymphoma. CA Cancer J Clin. 2005;55:368-376.

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17.4 Appendix 4: Groupe d’Etudes des Lymphomes Folliculaires (GELF) 
Criteria  
 
Involvement of > 3 nodal sites, each with a diameter of > 3 cm 
 
Any nodal or extranodal tumor mass with a diameter of > 7 cm 
 
B symptoms (night sweats, fever [temperature > 38°C], weight loss > 10% in the 
previous 6 months) 
 
Splenomegaly 
 
Pleural effusions or peritoneal ascites 
 
Cytopenias (leukocytes < 1.0 x 109/L and/or platelets < 100 x 109/L) 
 
Leukemia (> 5.0 x 109/L malignant cells)  
 
Solal-Celigny P. Lepage E, Brousse N, et al. Doxorubicin containing regimen with or 
without interferon alfa 2b for advanced follicular lymphomas: final analysis of survival 
and toxicity in the Group d’Etude des Lymphomes Folliculaire 86 trial. J Clin Oncol. 
1998;16:2332-2338. 

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A RANDOMIZED, DOUBLE-BLIND STUDY EVALUATING THE EFFICACY, 
SAFETY AND IMMUNOGENICITY OF ABP 798 COMPARED WITH 
RITUXIMAB IN SUBJECTS WITH CD20 POSITIVE B-CELL NON-HODGKIN 
LYMPHOMA (NHL)
SUMMARY OF CHANGES
Test Drug:
ABP 798
Protocol Number:
20130109
EudraCT number:  2013-005542-11
Study Phase:
3
Date and Version:
5.0, 17 July 2017
Key Contact:
Amgen Inc.:
Clinical Research Organization (CRO):
Clinical Research Study Manager
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, CA USA
91320
Phone:
Email: 
, PhD
Senior Project Director
PRA Health Sciences
500 South Oak Way, Green Park
Reading, Berkshire, RG2 6AD UK
Phone:
Mobile:
Email: 
Safety Contact:
PRA Drug Safety Center
North America
Phone:1-800-772-2215
Fax: 
1-888-772-6919
E-mail: CHOSafety@prahs.com
Europe, Asia, and Pacific Region
Phone:  +49.621.878.2154
FAX:  +44 1792 525 720
MHGSafety@prahs.com
This study will be conducted in compliance with the protocol, Good Clinical Practice 
(GCP) as set forth in the International Council for Harmonisation (ICH) guidelines on 
GCP (ICH E6), and applicable local regulatory requirements.
CONFIDENTIAL
This document is a confidential communication of Amgen, Inc. Acceptance of this document constitutes 
agreement by the recipient that no unpublished information contained herein shall be published or 
disclosed without prior written approval, except that this document may be disclosed to the appropriate
Institutional Review Board(s)/Independent Ethics Committee(s) under the condition that they keep it 
confidential.

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Rationale:
This amendment is issued to make the following changes:

To make minor, non-substantive grammatical and typographic corrections
(changes not detailed in this summary)

To add an optional additional PK sampling visit, and to clarify that subjects who 
agree to the optional additional PK sampling will also be required to have PK 
samples collected at week 1 and week 4 and at visit 4a (week 5)

To adjust the allowed subject age for inclusion in the study to ≥18 years 

To update the requirements for CT scans by increasing the allowed time from 
within 28 days to within 6 weeks for baseline CT scan, specifying that CT scans 
can be taken within 28 days prior to the EOS visit, and indicating that a CT scan 
is required before subjects take any new anti-cancer treatments.  

To redefine the criteria for defining low tumor burden as part of the study 
inclusion criteria

To clarify the parameters for exclusion criteria pertaining to participation in other 
investigational procedures and systemic corticosteroid use 

To specify the allowable time to within 8 days of visit 1 for obtaining height and 
weight for calculating study treatment dose levels

To clarify the infusion rate at which infusions may resume after Grade 2 and 
Grade 3 events have resolved 

To specify on which visits the physical examination and PK sampling procedures 
are required 

To clarify that the EOS biopsies for complete response confirmation are required 
if bone marrow involvement is identified at baseline, and if bone marrow 
assessments are not obtained, then complete response subjects are to be 
classified as partial responders  

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Summary of Changes
Any changes in the synopsis that also appear in the body of the protocol will appear only 
once in this summary of changes document, under the section number.
Abbreviations table: 
Add:
EU
European Union
HBcAb
Hepatitis B core antibody
HBV
Hepatitis B virus
US
United States
Remove: 
IND
Investigational New Drug
LD
Longest diameter
rituximab (US)
Food and Drug Administration US licensed rituximab
Section 8.1:
Figure 1.  Study Diagram
Add footnote:  
* Response assessments at study weeks 12 and 28
Wk = week
Section8.3Study Duration
Add: 
There is an additional visit at week 5 (visit 4a) for subjects who have agreed to the 
optional additional PK sampling (see Section 9.4).  Individual total study duration will 
be 32 weeks.
Section8.4.1Inclusion Criteria
Replace:
1.
Males and females ≥18 and < 80 years of age
3.
Stage 2, 3, or 4 (per Cotswold’s Modification of Ann Arbor Staging System; 
Appendix3) with measurable disease (per International Working Group)
subjects must have a baseline scan (computed tomography [CT]) of the neck 
(if palpable lymph node > 1.0 cm), chest, abdomen, and pelvis to assess 
disease burden within 28daysbefore randomization

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4.
Low tumor burden based on the Groupe d
'Etudes des Lymphomes Folliculaires 
(GELF) criteria (Appendix 4)
no spleen enlargement by CT assessment 
normal LDH
With:
1.
Males and females ≥18 years of age and older
3.
Stage 2, 3, or 4 (per Cotswold’s Modification of Ann Arbor Staging System; 
Appendix 3) with measurable disease (per International Working Group)
subjects must have a baseline scan (computed tomography [CT]) of the neck (if 
palpable lymph node > 1.0 cm), chest, abdomen, and pelvis to assess disease 
burden within 6weeksbefore randomization
4
Low tumor burden based on the Groupe d
'Etudes des Lymphomes Folliculaires 
(GELF) criteria (Appendix 4)
no splenomegaly > 16 cm by CTscan and no symptomatic splenomegaly
lactate dehydrogenase ≤upper limit of normal (ULN)
Section8.4.2 Exclusion Criteria
Replace: 
12.
Other investigational procedures while participating in this study are excluded
15.
Systemic corticosteroid use for 3 months before randomization (inhaled are 
allowable)
With: 
12.
Other investigational procedures that can impact the study data, results, or 
patient safetywhile participating in this study are excluded;participation in 
observational studies is allowed.
15.
Systemic corticosteroid use within3 months before randomization (inhaled are 
allowable)
Section8.4.3.2
Evaluations at Withdrawal
Add: 
perform all the procedures scheduled for the EOS visit (ie, week 28 visit 
[Section9.6]).  The week 28/EOS assessments will be performed 8 weeks 
(±7days) after the last dose of IP (unless the subject withdraws consent to do 
so).  Computed tomography is only required at early withdrawal if it has not been 

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performed within the previous 28 days.  Computed tomography is to be 
performed before the start of new anti-cancer treatment.
Section 8.5.1 Treatments Administered
Replace: 
The dose for ABP 798/rituximab will be calculated based on the height and weight 
obtained at baseline (Day 1) and the dose will remain the same throughout the study.
With: 
The dose for ABP 798/rituximab will be calculated based on the height and weight 
obtained within 8 days of visit 1 and the dose will remain the same throughout the 
study.
Section 8.5.6.2
Stopping Rules
Replace: 
For Grade 2 and Grade 3 events that have resolved, infusion may resume with a 50% 
reduction in infusion rate at the discretion of the investigator.  
With: 
For Grade 2 and Grade 3 events that have resolved, infusion can be initially resumed 
at not more than 50% of the previous rate at the discretion of the investigator.  
Section 8.6.1 Efficacy and Safety Measurements Assessed
Table 1.  Schedule of Assessments and Procedures
Add a new column, between Visits 4 and 5:
-
OPTIONAL:  Visit 4a/Week 5
Add an “X” for the following:
-
Physical examination on Visit 2/Week 2, Visit 3/Week 3, Visit 4/Week 4, 
Visit 5/Week 12, Visit 6/Week 20
-
PK sampling on OPTIONAL: Visit 4a/Week 5
Table 1: Footnotes: 
Replace: 
b Includes weight and height at baseline.
h The ABP 798/rituximab dose will be calculated based on the height and weight 
obtained at baseline (visit 1).

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i Subjects must have a baseline scan (computed tomography [CT]) of the neck (if 
palpable lymph node >1.0 cm), chest, abdomen, and pelvis to assess disease burden 
within 28 days before randomization.  
With: 
b Includes weight and height within 8 days of visit 1.
h The ABP 798/rituximab dose will be calculated based on the height and weight 
obtained within 8 days of visit 1.  
i Subjects must have a baseline scan (CT of the neck [if palpable lymph node >1.0 cm]), 
chest, abdomen, and pelvis to assess disease burden within 6 weeks before 
randomization.  
Add footnote “j” for CT scan at End of Study Visit: 
j End-of-study CT scan can be taken within 28 days prior to EOS visit.  Subjects 
who discontinue from the study due to disease progression should have a 
CT scan (as described in Section 9.6) prior to initiation of new anti-cancer 
treatment, if deemed clinically acceptable. 
Replace: 
j Subjects must have a bone marrow biopsy within 12 months before randomization.  
Previously confirmed positive bone marrow involvement does not need to be repeated 
for purposes of screening.  An end-of-study biopsy is required if bone marrow 
involvement is identified at baseline or disease progression is identified during the 
treatment phase.
With:
k Subjects must have a bone marrow biopsy within 12 months before randomization.  
Previously confirmed positive bone marrow involvement does not need to be repeated 
for purposes of screening.  An end-of-study biopsy is required if bone marrow 
involvement is identified at baseline for complete response (CR) confirmation.  If a 
confirmatory bone marrow assessment is not obtained, these subjects should be 
considered as only having a partial response (PR).
Update:
All footnote reference letters after “i” to adjust for the adition of footnote “j.”
Add:

Product: ABP 798
Clinical Study Protocol: 20130109
Date: 17 July 2017
Page 7 of 10
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Footnote “p” for PK sampling on Visit 4/Week 4 and OPTIONAL Visit 4a/Week 5: 
p Subjects who agree to optional additional PK sampling will also be required to 
have PK samples collected at 2 hours (± 1 hour) postdose at week 1 and week 4 
and at visit 4a (week 5).
Section 9
STUDY EVALUATIONS BY VISIT
Replace: 
After signing the informed consent, there are 8 visits, including a screening visit, a 
treatment visit on day 1 (day of first treatment; visit 1; week 1), treatment visits at visit 2 
(week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 12), visit 6 (week 20), and an 
EOS visit at week 28.  The first 12 subjects treated will remain at the clinic for 4 hours 
following the first (day 1) infusion for additional safety observation.  
With: 
After signing the informed consent, there are 8 planned visits, including a screening 
visit, a treatment visit on day 1 (day of first treatment; visit 1; week 1), treatment visits at 
visit 2 (week 2), visit 3 (week 3), visit 4 (week 4), visit 5 (week 12), visit 6 (week 20), and 
an EOS visit at week 28.  Subjects who agree to optional additional PK sampling 
will be required to attend an additional visit (4a at week 5) as well as remain in the 
clinic for sampling 2 hours (± 1 hour) after infusion on visits 1 (day 1) and 4 (week 
4). The first 12 subjects treated will remain at the clinic for 4 hours following the first 
(day 1) infusion for additional safety observation.
Section 9.1
Screening
Replace:
Assessments/procedures performed as routine standard of care, prior to the subject 
signing informed consent, and according to the criteria outlined in Section 10, can be 
used for screening purposes as long as the assessments/procedures were performed 
within 28 days before randomization (except for bone marrow biopsy).

baseline computed tomography (CT) of the neck (if palpable lymph node 
>1.0 cm), chest, abdomen, and pelvis
With:
Assessments/procedures performed as routine standard of care, prior to the subject 
signing informed consent, and according to the criteria outlined in Section 10, can be 
used for screening purposes as long as the assessments/procedures were performed 
within 28 days before randomization (except for bone marrow biopsy and CT scan).

Product: ABP 798
Clinical Study Protocol: 20130109
Date: 17 July 2017
Page 8 of 10
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
baseline CT of the neck (if palpable lymph node >1.0 cm), chest, abdomen, and 
pelvis within 6 weeks before randomization
Add:
(Height and weight are required for IXRS randomization and must be collected 
within 8 days of visit 1).
Section 9.2
Baseline (Day 1, first day of administration of investigational product)
Replace: 

physical examination, including evaluation of body systems and height and 
weight
The dose calculation for ABP 798 or rituximab will be based on the height and weight 
obtained at baseline (day 1).  
With: 

physical examination, including evaluation of body systems and baseline height 
and weight; baseline height and weight will be measured within 8 days of 
visit 1 to allow use in randomization of subjects within 8 days of visit 1
The dose calculation for ABP 798 or rituximab will be based on the height and weight 
obtained within 8 days of visit 1.  
Add:
Subjects who have agreed to additional optional PK sampling will have a 2 hour 
(± 1 hour) post dose PK sample collected.  
Section 9.3
Visit 2 (Week 2), Visit 3 (Week 3), and Visit 4 (Week 4)
Replace: 

clinical disease assessment
With:

physical examination and clinical disease assessment
Add: 
At visit 4, subjects who have agreed to additional optional PK sampling will have a 
2 hour (± 1 hour) post dose sample collected.
Add: Section 9.4
Visit 4a (Week 5): Optional PK Sampling
At visit 4a (week 5 ± 3 days) subjects who have agreed to additional optional PK 
sampling should return for PK sample collection.  No study treatment will be given 
at this visit.

Product: ABP 798
Clinical Study Protocol: 20130109
Date: 17 July 2017
Page 9 of 10
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Section 9.5
Visit 5 (Week 12) and Visit 6 (Week 20)
Replace:

clinical disease assessment
With: 

physical examination and clinical disease assessment
Add: 
The following procedure / assessment will be performed for all subjects after 
treatment on week 12 only:

Immediately after completion of the infusion, postdose PK samples will be 
collected.
Section 9.6
Week 28/End of Study
Add:
Subjects who discontinue from the study due to disease progression should have 
a CT scan (as described below) prior to initiation of new anti-cancer treatment, if 
deemed clinically acceptable.
Replace: 
At the week 28/EOS visit or at the time of early discontinuation, the following 
assessments will be performed:

bone marrow biopsy (only required if bone marrow involvement is identified at 
baseline or disease progression is identified during the treatment phase)
With: 
At the EOS visit (week 28 or 8 weeks after the last dose of IP), the following 
assessments will be performed:

bone marrow biopsy (only required if bone marrow involvement is identified at 
baseline for CR confirmation; if a confirmatory bone marrow assessment is 
not obtained, these subjects should be considered as only having a PR).  
The bone marrow biopsy can be performed at ± 14 days in relation to the 
study visit date.
Section 10.1
Response Assessments
Replace: 
Clinical disease assessments will be performed by the Investigator or sub investigator 
and will be submitted to the central imaging vendor, if applicable.
With:

Product: ABP 798
Clinical Study Protocol: 20130109
Date: 17 July 2017
Page 10 of 10
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Clinical disease assessments, which will be performed in conjunction with physical 
examinations, will be performed by the nvestigator or sub-investigator and will be 
submitted to the central imaging vendor, if applicable.
Section 10.3
Physical Examination
Replace:
Body weight (kg) will be measured without shoes or jacket.  Height and weight will be 
determined at baseline.
With: 
Body weight (kg) will be measured without shoes or jacket.  Height and weight will be 
determined within 8 days of visit 1.
Section 10.6
Clinical Laboratory Testing
Add:
Serology (local laboratory):  HBsAg, hepatitis B core antibody, and HCV antibody.
Section 16
REFERENCE LIST
Remove: 
Fisher RI, LeBlanc M, Press OW, et al. New treatment options have changed the 
survival of patients with follicular lymphoma. J Clin Oncol. 2005; 23:8447–8452.

Product: ABP 798
Clinical Study Protocol: 20130109
Date: 24 June 2016 
Page 1 of 17
Confidential
A RANDOMIZED, DOUBLE-BLIND STUDY EVALUATING THE EFFICACY, 
SAFETY AND IMMUNOGENICITY OF ABP 798 COMPARED WITH 
RITUXIMAB IN SUBJECTS WITH CD20 POSITIVE B-CELL NON-HODGKIN 
LYMPHOMA (NHL)
SUMMARY OF CHANGES
Test Drug:
ABP 798
Protocol Number:
20130109
EudraCT number:  2013-005542-11
Study Phase:
3
Date and Version:
4.0, 24 June 2016
Key Contact:
Amgen Inc.:
Clinical Research Organization (CRO):
Clinical Research Study Manager
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, CA USA
91320
Phone:
Email: 
 PhD
Senior Project Director
PRA Health Sciences
500 South Oak Way, Green Park
Reading, Berkshire, RG2 6AD UK
Phone:
Mobile:
Email: 
Safety Contact:
PRA Drug Safety Center
North America
Phone:1-800-772-2215
Fax: 
1-888-772-6919
E-mail: CHOSafety@prahs.com
Europe, Asia, and Pacific Region
Phone:  +49.621.878.2154
FAX:  +44 1792 525 720
MHGSafety@prahs.com
This study will be conducted in compliance with the protocol, Good Clinical Practice 
(GCP) as set forth in the International Conference on Harmonisation (ICH) guidelines on 
GCP (ICH E6), and applicable local regulatory requirements.
CONFIDENTIAL
This document is a confidential communication of Amgen, Inc. Acceptance of this document constitutes 
agreement by the recipient that no unpublished information contained herein shall be published or 
disclosed without prior written approval, except that this document may be disclosed to the appropriate
Institutional Review Board(s)/Independent Ethics Committee(s) under the condition that they keep it 
confidential.

Product: ABP 798
Clinical Study Protocol: 20130109
Date: 24 June 2016 
Page 2 of 17
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Rationale:
This amendment is issued to make the following changes:

To make minor, non-substantive grammatical and typographic corrections
(changes not detailed in this summary)

To update Amgen key contact information

To update International Council for Harmonisation (ICH) terminology

To add a citation in support of rituximab monotherapy

To modify the Inclusion Criteria:
1. To specify the biopsy sites for histologic confirmation
2. To extend the window for histologic confirmation to 12 months to conform 
to standard of care for non-Hodgkin lymphoma (NHL)
3. To extend the window for bone marrow biopsy to 12 months to conform to 
standard of care
4. To eliminate the need for subjects to undergo a bone marrow biopsy 
within 12 months if they previously had a bone marrow biopsy with a 
positive result
5. To correct the nodal or extranodal mass size according to Groupe 
d'Etudes des Lymphomes Folliculaires (GELF) criteria
6. To specify splenic enlargement according to GELF criteria should be 
assessed by computed tomography (CT)
7. To specify the site of serous effusions according to GELF criteria
8. To elaborate on the specific nature of GELF B symptoms

To specify the dose of ABP 798/rituximab will be calculated based on height and 
weight obtained at baseline, and that the dose will remain the same throughout 
the study

To add stopping criteria for infusion-related reactions

To add additional monitoring requirements for infusion-related hypersensitivity 
reactions

To specify investigational product dispensation delegation to maintain treatment 
blinding

To detail the conditions for use of a non-contrast CT for disease burden 
assessment

To allow for a 3 day window for collection of baseline hematology and serum 
chemistry parameters

Product: ABP 798
Clinical Study Protocol: 20130109
Date: 24 June 2016 
Page 3 of 17
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
To specify the timeframe for randomization (within 8 days before the baseline 
visit)

To specify that clinical disease assessments should be performed by the 
investigator or sub-investigator