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)

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DRUG	parsaclisib	parsaclisib will be administered once daily at 20 mg for 8 weeks followed by 2.5 mg once daily.
DRUG	rituximab	rituximab will be administered intravenously on select days as per protocol.
DRUG	obinutuzumab	obinutuzumab will be administered intravenously on select days as per protocol.

Timeline

• Start date: 2022-12-30
• Primary completion: 2028-12-20
• Completion: 2032-08-25
• First posted: 2021-03-15
• Last updated: 2022-07-18

Regulatory

• FDA-regulated drug study