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

Sponsor
Incyte Corporation
Study ID
NCT04849715
Phase
PHASE3
Status
Withdrawn

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 11, 2022
Status verified
Apr 2022
Primary completion
Aug 15, 2030
Completion
Jul 7, 2034

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment Group A
    Participants will be administered parsaclisib once daily and will receive Bendamustine and Rituximab periodically for 6 months.
  • Placebo Comparator: Treatment group B
    Participants will be administered placebo once daily and will receive Bendamustine and Rituximab periodically for 6 months.

Primary Outcome Measure

Progression Free Survival [ Time Frame: 7 years ]

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