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

NCT04849715 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2022-04-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-11
Primary Completion
2030-08-15
Completion
2034-07-07
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04849715 on ClinicalTrials.gov