A Phase 3 Study to Compare the Efficacy of ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL).
NCT07784101 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280
Last updated 2026-08-25
Summary
This study aims to compare the efficacy and safety of ICP-248 in combination with orelabrutinib versus pirtobrutinib in patients with relapsed or refractory mantle cell lymphoma (r/r MCL).
Conditions
- Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Interventions
- DRUG
-
ICP-248
Administered orally
- DRUG
-
Pirtobrutinib
Administered orally
- DRUG
-
Administered orally
Sponsors & Collaborators
-
Beijing InnoCare Pharma Tech Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-10-31
- Primary Completion
- 2032-10-31
- Completion
- 2033-12-31
Countries
- China
Study Locations
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