Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)

NCT ID: NCT04434937

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2023-10-13

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

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

parsaclisib

parsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits

Group Type: EXPERIMENTAL

parsaclisib

Intervention Type: DRUG

parsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits

Interventions

parsaclisib

parsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits

Intervention Type: DRUG

Other Intervention Names

INCB050465

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Biosciences Japan GK

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Incyte Medical Monitor

Role: STUDY_DIRECTOR

Incyte Biosciences Japan GK

Locations

Ja-Aichi Anjo Kosei Hospital

Anjo, , Japan

University of Fukui Hospital

Fukui, , Japan

Jcho Kyushu Hospital

Fukuoka, , Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, , Japan

Fukushima Medical University Hospital

Fukushima, , Japan

Kansai Medical University Hospital

Hirakata, , Japan

Hokuyukai Sapporo Hokuyu Hospital

Hokkaido, , Japan

Hyogo College of Medicine Hospital

Hyōgo, , Japan

Nho Mito Medical Center

Ibaraki, , Japan

Tokai University Hospital

Isehara, , Japan

Jiaikai Imamura General Hospital

Kagoshima, , Japan

Kobe City Medical Center General Hospital

Kobe, , Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, , Japan

Nho Matsumoto Medical Center

Matsumoto, , Japan

Nho Shikoku Cancer Center

Matsuyama, , Japan

Nagano Red Cross Hospital

Nagano, , Japan

National Hospital Organization Nagoya Medical Center

Nagoya, , Japan

Japanese Red Cross Nagoya Daini Hospital

Nagoya, , Japan

Red Cross Nagoya Daini Hospital

Nagoya, , Japan

Tenri Hospital

Nara, , Japan

Miyagi Cancer Center

Natori, , Japan

Niigata Cancer Center Hospital

Niigata, , Japan

Okayama University Hospital

Okayama, , Japan

Ogaki Municipal Hospital

Ōgaki, , Japan

Nho Hokkaido Cancer Center

Sapporo, , Japan

Tohoku University Hospital

Sendai, , Japan

Shizuoka Cancer Center

Shizuoka, , Japan

Nippon Medical School Hospital

Tokyo, , Japan

Yokohama Municipal Citizens Hospital

Yokohama, , Japan

Yokohama City University Medical Center

Yokohama, , Japan

Countries

Japan

References

Fukuhara N, Yoshida I, Ishiguro T, Fujimoto K, Kuroda J, Uchida T, Yamamoto R, Ogawa Y, Hiramatsu Y, Ito T, Katagiri S, Nakazato T, Suzukawa K, Kinami K, Zhou M, Negoro E. PI3Kdelta Inhibitor Parsaclisib in Japanese Patients With Relapsed or Refractory Follicular Lymphoma. Cancer Sci. 2025 Aug;116(8):2189-2197. doi: 10.1111/cas.70046. Epub 2025 May 14.

Reference Type: DERIVED

PMID: 40365847 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

INCB 50465-213

Identifier Type: -

Identifier Source: org_study_id