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)

Sponsor
Incyte Corporation
Study ID
NCT04796922
Phase
PHASE3
Status
Withdrawn

Conditions

  • Follicular Lymphoma ( FL)
  • Marginal Zone Lymphoma (MZL)

Eligibility Criteria

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

Interventions

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

Study Details

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) .

Key Dates

Start date
Dec 30, 2022
Status verified
Jul 2022
Primary completion
Dec 20, 2028
Completion
Aug 25, 2032

Study Design

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

Arms

  • Experimental: Treatment Group A
    Participants will be administered with parsaclisib in combination with investigator choice of rituximab or obinutuzumab.
  • Placebo Comparator: Treatment Group B
    Participants will be administered with placebo in combination with investigator choice of rituximab or obinutuzumab

Primary Outcome Measure

Progression Free Survival (PFS) in R/R FL and MZL participants [ Time Frame: 62 months ]

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