drugset / Trial / 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)
RandomizedParallel-groupTriple-blindTreatment
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) .
Timeline
- Start
- 2022-12-30
- Primary completion
- 2028-12-20
- Completion
- 2032-08-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Parsaclisib | Small molecule | 2.5 mg | — |
| Background | Obinutuzumab | Monoclonal antibody | — | Intravenous |
| Background | Rituximab | Monoclonal antibody | — | Intravenous |