NCT05495464

A Pilot "Window-3" Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if giving acalabrutinib, rituximab, and brexucabtagene autoleucel to patients with previously untreated high-risk mantle cell lymphoma (MCL) can help to control the disease.

Detailed description

PRIMARY OBJECTIVES: To determine the safety profile of the acalabrutinib plus rituximab combination followed by CAR T-cell therapy in newly diagnosed high risk MCL patients. SECONDARY OBJECTIVES: To evaluate efficacy measured by complete response (CR) rate and progression free survival (PFS) of the acalabrutinib plus rituximab combination followed by CAR T-cell therapy in newly diagnosed high risk MCL patients.

Conditions

• Lymphoma
• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Acalabrutinib	Given by PO
DRUG	Rituximab	Given by IV (vein)
OTHER	Brexucabtagene Autoleucel	Given by IV (vein)
DRUG	Cyclophosphamide	Given by IV (vein)
DRUG	Fludarabine Phosphate	Given by IV (vein)

Timeline

• Start date: 2022-11-18
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2022-08-10
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study