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

COMPLETEDPHASE2

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

A Phase 2, Multicenter, Open-Label Study of Parsaclisib, a PI3Kδ Inhibitor, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)

NCT04434937•Incyte Biosciences Japan GK

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

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
+3 more criteria

Locations (30)

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

Key Dates

Start Date

September 30, 2020

Primary Completion Date

February 16, 2023

Completion Date

October 13, 2023

Last Updated

October 23, 2024

Enrollment

ACTUAL participants

Conditions

Lymphoma

Interventions

parsaclisib

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 23, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

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