drugset / Trial / NCT04796922

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)

NCT04796922

Phase 3 Withdrawn Incyte Corporation
RandomizedParallel-groupTriple-blindTreatment

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) .

Timeline

Start
2022-12-30
Primary completion
2028-12-20
Completion
2032-08-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Parsaclisib Small molecule 2.5 mg
Background Obinutuzumab Monoclonal antibody Intravenous
Background Rituximab Monoclonal antibody Intravenous