NCT04849715

A Study of Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma

A Phase 3, Randomized, Double-Blind Study Comparing Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab (BR), With Placebo and BR for the Treatment of Newly Diagnosed Mantle Cell 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• Status: Withdrawn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 BR versus placebo plus BR as first-line treatment of participants with newly diagnosed MCL.

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	parsaclisib	parsaclisib will be administered orally once daily.
DRUG	rituximab	rituximab is administered IV on Day 1 of each 28-day cycle for 6 cycles.
DRUG	bendamustine	bendamustine is administered IV on Day 1 and 2 of each 28-day cycle for 6 cycles.
DRUG	Placebo	placebo will be administered orally once daily

Timeline

• Start date: 2022-03-11
• Primary completion: 2030-08-15
• Completion: 2034-07-07
• First posted: 2021-04-19
• Last updated: 2022-04-29

Regulatory

• FDA-regulated drug study