drugset / Trial / NCT07285590
Clinical Trial to Evaluate the Efficacy and Safety of Pirtobrutinib With Rituximab in Patients With Mantle Cell Lymphoma
Phase 2
Recruiting
50 enrolled
Spanish Lymphoma Cooperative Group
Eli Lilly and Company · collabEvidenze CRO · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a multicenter, international, open-label, single-arm phase II clinical trial designed to evaluate the activity and safety of a combination therapy with pirtobrutinib and rituximab (P-R) in treatment-naïve adult patients diagnosed with indolent clinical forms of Mantle Cell Lymphoma (MCL). The study applies a Simon's two-stage design, with an interim analysis after the first 16 patients to determine continuation based on complete remission rate (CRR) after 6 cycles.
Timeline
- Start
- 2025-09-30
- Primary completion
- 2032-12
- Completion
- 2032-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pirtobrutinib | Other / unclassified | — | — |
| Subject | Rituximab | Monoclonal antibody | — | — |