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Pirtobrutinib and Rituximab in Indolent Mantle Cell Lymphoma
NCT07285590Phase 2
Key facts
- Status
- Recruiting
- Start
- Sep 2025
- Primary completion
- Dec 2032
- Countries
- 2
- Sponsor
- GELTAMO
- Modality
- Small Molecules
- Drugs
- pirtobrutinib
- Conditions
- mantle cell lymphoma (MCL)
01
Overview
Phase 2, open-label, single-arm trial of pirtobrutinib in mantle cell lymphoma (MCL), sponsored by GELTAMO. Primary endpoint: Complete Remission Rate. Started Sep 2025; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Pirtobrutinib with rituximab
Pirtobrutinib + Rituximab combination for at least 24 cycles
03
Who it enrols
Treatment-naïve adult patients with indolent, asymptomatic Mantle Cell Lymphoma, ECOG 0-1, and adequate organ function.
04
Endpoints
Primary
Complete Remission Rate
Secondary
Objective Response Rate
Minimal Residual Disease
Safety and Tolerability
Health-related Quality of Life
Biological Characterization
Complete Remission Rate
Minimal Residual Disease Response
Duration of Response
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