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)

• Status: Not yet recruiting
• Trial end date: 2031-09-28
• Target enrollment: 0
• Participant gender: All

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) .

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Obinutuzumab; Rituximab

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

• 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.

• Adequate organ functions including hematopoiesis, liver, and kidney

• 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.