Clinical trial NCT04434937: Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)
Official title: A Phase 2, Multicenter, Open-Label Study of Parsaclisib, a PI3Kδ Inhibitor, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: Follicular Lymphoma
Parsaclisib
PI3Kδ Inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2020-06-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Male or female Japanese participant who must be ≥ 18 years of age
* Ability to comprehend and willingness to sign a written ICF and comply with all study visits and procedures
* Histologically confirmed, relapsed or refractory, FL Grade 1, 2, and 3a
* Ineligible for HSCT
* Must have been treated with at least 2 prior systemic therapies for FL
* Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures \> 1.5 cm in the LD and ≥ 1.0 cm in the LPD, respectively) as assessed by CT or MRI
* Participants must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy collected after the completion of last therapy. An earlier archived lymph node or tissue biopsy is acceptable if hospitalization is required for biopsy (eg. no superficial lymph node) and SUVmax by FDG-PET is \< 14
* ECOG performance status 0 to 2
* Life expectancy ≥ 12 weeks
* Adequate hematologic, hepatic, and renal functions ANC ≥ 1.0 × 109/L Hemoglobin ≥ 8.0 g/dL. Platelet count ≥ 50 × 109/L. Total bilirubin ≤ 1.5 × ULN. Participants with documented history of Gilbert's syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible.

ALT/AST ≤ 2.5× ULN or ≤ 5 × ULN in the presence of liver involvement. Calculated creatinine clearance ≥ 40 mL/min by the Cockcroft-Gault Equation or the estimated glomerular filtration rate ≥ 40 mL/min/1.73 m2 using the Modification of Diet in Renal Disease formula.

* Female participants agree to use medically acceptable contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test before the start of study drug administration.
* Female participants of childbearing potential must understand and accept that pregnancy must be avoided during participation in the study.
* Male participants should avoid fathering children from screening through at least 93 days after the last dose of study treatment.

Exclusion Criteria:

* Known histological transformation from indolent NHL to DLBCL
* History of central nervous system lymphoma (either primary or metastatic)
* Prior treatment with the following:

  1. Selective PI3Kδ or pan-PI3K inhibitors (eg, idelalisib, copanlisib, duvelisib, etc).
  2. Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
* Allogeneic SCT within the last 6 months, or autologous SCT within the last 3 months before the date of study treatment administration
* Active graft-versus-host disease
* Use of immunosuppressive therapy within 28 days of the date of study treatment administration
* Concurrent anticancer therapy
* Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease
* Current or previous other malignancy within 3 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval.
* Hepatitis B (HBV) or HCV infection
* Current New York Heart Association Class II to IV congestive heart failure or uncontrolled arrhythmia

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to approximately 3 years
Secondary outcomes:
measure: Complete Response Rate (CRR)
timeFrame: up to approximately 3 years
measure: Duration of Response (DOR)
timeFrame: up to 20.0 months
measure: Progression-free Survival (PFS)
timeFrame: up to approximately 3 years
measure: Overall Survival
timeFrame: up to approximately 3 years
measure: Best Percentage Change in Target Lesion Size From Baseline, as Determined by Independent Review Committee and the Investigator
timeFrame: up to approximately 3 years
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: up to 1041 days
measure: Number of Participants With Any Grade 3 or Higher TEAE
timeFrame: up to 1041 days
Other outcomes:
Locations:
city: Anjo
country: Japan
facility: Ja-Aichi Anjo Kosei Hospital
city: Fukui
country: Japan
facility: University of Fukui Hospital
city: Fukuoka
country: Japan
facility: Jcho Kyushu Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
city: Hokkaido
country: Japan
facility: Hokuyukai Sapporo Hokuyu Hospital
city: Hyogo
country: Japan
facility: Hyogo College of Medicine Hospital
city: Ibaraki
country: Japan
facility: Nho Mito Medical Center
city: Isehara
country: Japan
facility: Tokai University Hospital
city: Kagoshima
country: Japan
facility: Jiaikai Imamura General Hospital
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Matsumoto
country: Japan
facility: Nho Matsumoto Medical Center
city: Matsuyama
country: Japan
facility: Nho Shikoku Cancer Center
city: Nagano
country: Japan
facility: Nagano Red Cross Hospital
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
city: Nagoya
country: Japan
facility: Japanese Red Cross Nagoya Daini Hospital
city: Nagoya
country: Japan
facility: Red Cross Nagoya Daini Hospital
city: Nara
country: Japan
facility: Tenri Hospital
city: Natori
country: Japan
facility: Miyagi Cancer Center
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Ogaki
country: Japan
facility: Ogaki Municipal Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Sapporo
country: Japan
facility: Nho Hokkaido Cancer Center
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Yokohama
country: Japan
facility: Yokohama Municipal Citizens Hospital
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
Study officials:
affiliation: Incyte Biosciences Japan GK
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References: