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Rocbrutinib in Relapsed or Refractory Mantle Cell Lymphoma
NCT07377578Phase 3
Key facts
- Status
- Recruiting
- Start
- Feb 2026
- Primary completion
- May 2031
- Countries
- 1
- Sponsor
- Lupeng Pharmaceutical
- Modality
- Small Molecules
- Drugs
- rocbrutinib
- Conditions
- mantle cell lymphoma (MCL)
01
Overview
Phase 3, randomised, open-label trial of rocbrutinib in mantle cell lymphoma (MCL) (2 arms), sponsored by Lupeng Pharmaceutical. Primary endpoint: Progression-Free Survival at 30 months. Started Feb 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Arm A (Rocbrutinib)
Rocbrutinib monotherapy
Arm B (Investigator's Choice)
Investigator's choice of ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib
03
Endpoints
Primary
Progression-Free Survival
Secondary
Progression-Free Survival
Overall Response Rate
Duration of Response
Overall Survival
Treatment-Emergent Adverse Events
Treatment-Related Adverse Events
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