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

NCT04434937 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: INCB 50465-213
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 30

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

Keywords

Follicular Lymphoma; Parsaclisib; PI3Kδ Inhibitor

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) as defined by revised response criteria for lymphoma, as determined by an Independent Review Committee (IRC). CR: target nodes/nodal masses regressed to ≤1.5 centimeters (cm) in the longest transverse diameter (LDi); no nonmeasured lesions; regression to normal for organ enlargement; no new lesions; and normal bone marrow by morphology and negative immunohistochemistry if indeterminate. PR: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extranodal sites; absent/regressed nonmeasured lesions (but no increase); spleen regressed by \>50% in length beyond normal; and no new lesions.

  up to approximately 3 years

Secondary Outcomes (7)

• Complete Response Rate (CRR)

  up to approximately 3 years

• Duration of Response (DOR)

  up to 20.0 months

• Progression-free Survival (PFS)

  up to approximately 3 years

• Overall Survival

  up to approximately 3 years

• Best Percentage Change in Target Lesion Size From Baseline, as Determined by Independent Review Committee and the Investigator

  up to approximately 3 years

Study Arms (1)

parsaclisib

EXPERIMENTAL

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

Drug: parsaclisib

Interventions

parsaclisib DRUG

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

Also known as: INCB050465

parsaclisib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known histological transformation from indolent NHL to DLBCL
• History of central nervous system lymphoma (either primary or metastatic)
• Prior treatment with the following:
• Selective PI3Kδ or pan-PI3K inhibitors (eg, idelalisib, copanlisib, duvelisib, etc).
• 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

Sponsors & Collaborators

• Incyte Biosciences Japan GK: lead

Study Sites (30)

Ja-Aichi Anjo Kosei Hospital

Anjo, 446-8602, Japan

Location

University of Fukui Hospital

Fukui, 910-1193, Japan

Location

Jcho Kyushu Hospital

Fukuoka, 806-8501, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Fukushima Medical University Hospital

Fukushima, 960-1295, Japan

Location

Kansai Medical University Hospital

Hirakata, 573-1191, Japan

Location

Hokuyukai Sapporo Hokuyu Hospital

Hokkaido, 003-0006, Japan

Location

Hyogo College of Medicine Hospital

Hyōgo, 663-8501, Japan

Location

Nho Mito Medical Center

Ibaraki, 311-3193, Japan

Location

Tokai University Hospital

Isehara, 259-1193, Japan

Location

Jiaikai Imamura General Hospital

Kagoshima, 890-0064, Japan

Location

Kobe City Medical Center General Hospital

Kobe, 650-0047, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Nho Matsumoto Medical Center

Matsumoto, 399-8701, Japan

Location

Nho Shikoku Cancer Center

Matsuyama, 791-0280, Japan

Location

Nagano Red Cross Hospital

Nagano, 380-8582, Japan

Location

National Hospital Organization Nagoya Medical Center

Nagoya, 460-0001, Japan

Location

Japanese Red Cross Nagoya Daini Hospital

Nagoya, 466-8650, Japan

Location

Red Cross Nagoya Daini Hospital

Nagoya, 4668650, Japan

Location

Tenri Hospital

Nara, 632-8552, Japan

Location

Miyagi Cancer Center

Natori, 981-1293, Japan

Location

Niigata Cancer Center Hospital

Niigata, 951-8566, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Ogaki Municipal Hospital

Ōgaki, 5038502, Japan

Location

Nho Hokkaido Cancer Center

Sapporo, 003-0804, Japan

Location

Tohoku University Hospital

Sendai, 980-8574, Japan

Location

Shizuoka Cancer Center

Shizuoka, 411-8777, Japan

Location

Nippon Medical School Hospital

Tokyo, 113-8603, Japan

Location

Yokohama Municipal Citizens Hospital

Yokohama, 221-0855, Japan

Location

Yokohama City University Medical Center

Yokohama, 232-0024, Japan

Location

Related Publications (1)

• 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.

  PMID: 40365847 DERIVED

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular

Interventions

parsaclisib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Incyte Medical Monitor

  Incyte Biosciences Japan GK

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 17, 2020
• Study Start: September 30, 2020
• Primary Completion: February 16, 2023
• Study Completion: October 13, 2023
• Last Updated: October 23, 2024
• Results First Posted: January 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

JP (30)