To Evaluate Efficacy and Safety of Parsaclisib Plus Either Rituximab or Obinutuzumab in R/R Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) (CITADEL-302)

NCT ID: NCT04796922

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-30
• Study Completion Date: 2032-08-25

Brief Summary

This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus investigator's choice of either rituximab or obinutuzumab versus placebo plus investigator's choice of rituximab or obinutuzumab for the treatment of participants with R/R FL or MZL. The Participants will be stratified in a 1:1 randomization ratio by investigator's choice of rituximab or obinutuzumab prior to randomization, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (MZL or FL) .

Conditions

Follicular Lymphoma ( FL); Marginal Zone Lymphoma (MZL)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment Group A

Participants will be administered with parsaclisib in combination with investigator choice of rituximab or obinutuzumab.

Group Type: EXPERIMENTAL

parsaclisib

Intervention Type: DRUG

parsaclisib will be administered once daily at 20 mg for 8 weeks followed by 2.5 mg once daily.

rituximab

Intervention Type: DRUG

rituximab will be administered intravenously on select days as per protocol.

obinutuzumab

Intervention Type: DRUG

obinutuzumab will be administered intravenously on select days as per protocol.

Treatment Group B

Participants will be administered with placebo in combination with investigator choice of rituximab or obinutuzumab

Group Type: PLACEBO_COMPARATOR

rituximab

Intervention Type: DRUG

rituximab will be administered intravenously on select days as per protocol.

obinutuzumab

Intervention Type: DRUG

obinutuzumab will be administered intravenously on select days as per protocol.

Interventions

parsaclisib

parsaclisib will be administered once daily at 20 mg for 8 weeks followed by 2.5 mg once daily.

Intervention Type: DRUG

rituximab

rituximab will be administered intravenously on select days as per protocol.

Intervention Type: DRUG

obinutuzumab

obinutuzumab will be administered intravenously on select days as per protocol.

Intervention Type: DRUG

Other Intervention Names

INCB050465

Eligibility Criteria

Inclusion Criteria

• Male and female participants aged 18 years or older (Japan, aged 20 years or older).
• Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL
• Prior systemic treatment with at least 1 anti-CD20 mAb (either as monotherapy or in combination as chemoimmunotherapy)
• Documented disease that has relapsed or progressed or was refractory after the most recent prior systemic therapy. Note: Participants must not be refractory to anti-CD20 mAb
• Radiographically (CT, MRI) measurable lymphadenopathy per the Lugano criteria for response assessment (Cheson et al 2014).
• ECOG PS of 0 to 2
• Adequate organ functions including hematopoiesis, liver, and kidney
• Willingness to avoid pregnancy or fathering children

Exclusion Criteria

• Women who are pregnant or breastfeeding.
• Known histological transformation from indolent NHL to an aggressive NHL (eg, diffuse large B-cell lymphoma).
• Presence of CNS lymphoma (either primary or secondary) or leptomeningeal disease.
• Prior treatment with PI3K inhibitors.
• Inadequate washout of immunosuppressive therapy, anticancer medications and investigational drugs.
• Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, GI, endocrine, pulmonary, neurological, cerebral, cardiac, infectious, or psychiatric disease.
• Known HIV infection.
• HBV or HCV infection: Participants positive for HBsAg or anti-HBc will be eligible if they are negative for HBV-DNA; these participants must receive prophylactic antiviral therapy. Participants positive for HCV antibody will be eligible if they are negative for HCV-RNA.
• History of other malignancy within 2 years of study entry.
• Any condition that would, in the investigator's judgment, interfere with full participation in the study.

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

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

INCB 50465-302

Identifier Type: -

Identifier Source: org_study_id