A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Parsaclisib Plus Investigator's Choice of Either Rituximab or Obinutuzumab in Participants With Relapsed or Refractory Follicular Lymphoma and Marginal Zone Lymphoma

Phase 3

• Conditions: Follicular Lymphoma (FL) , Marginal Zone Lymphoma (MZL)

• Registration Number: JPRN-jRCT2031210296
• Lead Sponsor: eda Eiji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified