NCT05529069

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if the combination of pirtobrutinib (also called LOXO-305) and venetoclax can help to control mantle cell lymphoma (MCL) that is relapsed (has come back) or refractory (has not responded to therapy).

Detailed description

PRIMARY OBJECTIVE: • To determine the efficacy (overall response rate) and safety profile of the Pirtobrutinib plus venetoclax combination in relapsed refractory MCL patients SECONDARY OBJECTIVE: • To evaluate the survival (including overall and progression-free survival) of the Pirtobrutinib plus venetoclax combination in relapsed refractory MCL patients. EXPLORATORY STUDIES: •Exploratory studies are planned on the trial and the final analysis and methodology including bio-informatics analysis

Conditions

• Mantle Cell Lymphoma
• Non Hodgkin Lymphoma
• Hematologic Malignancy

Interventions

Type	Name	Description
DRUG	Pirtobrutinib	Given by PO
DRUG	Venetoclax	Given by PO

Timeline

• Start date: 2023-01-25
• Primary completion: 2027-04-28
• Completion: 2027-04-28
• First posted: 2022-09-06
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study