NCT04566887

Acalabrutinib With R-CHOP in Previously Untreated Mantle Cell Lymphoma

A Phase II Study of Acalabrutinib in Combination With R-CHOP Chemotherapy in Previously Untreated Mantle Cell Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, non-randomized, phase II clinical trial conducted in Canada. The purpose of the study is to determine the remission rate of acalabrutinib in combination with R-CHOP in patients with previously untreated mantle cell lymphoma prior to autologous stem cell transplantation. This study is composed of 2 cohorts, A and B. In Cohort A all patients will receive six cycles of R-CHOP chemotherapy together with continuous acalabrutinib at the standard dose twice per day orally. All patients will undergo response assessment at the end of six cycles of R-CHOP + acalabrutinib with CT scan, PET/CT scan, and bone marrow biopsy. Responding patients will proceed with stem cell mobilization, apheresis, and processing. Following ASCT, patients will receive standard maintenance rituximab every 3 months for 2 years. Enrollment for Cohort A component of the study has been completed. Cohort B, involves using acalabrutinib with R-CHOP (same as Group A) but without an autologous stem cell transplant (ASCT) as part of the regimen. The study doctors hope to evaluate how participants respond to the treatment in terms of the time between treatment initiation and time when stable disease is achieved. The enrollment for cohort B is currently ongoing.

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Acalabrutinib	Administered as 100mg tablets.
DRUG	R-CHOP chemotherapy	R-CHOP chemotherapy

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-09-30
• Completion: 2032-04-30
• First posted: 2020-09-28
• Last updated: 2025-02-18

Locations

5 sites across 1 country: Canada