Overview

Clinical Trial to Evaluate the Efficacy and Safety of Pirtobrutinib With Rituximab in Patients With Mantle Cell Lymphoma

Status:
RECRUITING
Trial end date:
2032-12-01
Target enrollment:
Participant gender:
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-nave 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.
Phase:
PHASE2
Details
Lead Sponsor:
Grupo Espaol de Linfomas y Transplante Autlogo de Mdula sea
Collaborators:
Eli Lilly and Company
Evidenze Health Espaa (CRO)
Treatments:
pirtobrutinib
Rituximab