Acalabrutinib With R-CHOP in Previously Untreated Mantle Cell Lymphoma

Official Title

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

Summary:

This is a multicentre, 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. 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.

Trial Description

Primary Outcome:

• Complete response (CR) rate by PET/CT scan using Lugano Classification for Malignant Lymphoma

• Adverse events of acalabrutinib and R-CHOP by using CTCAE version 5.0
• Measures of efficacy by using the RECIL 2017 criteria.
• Rate of minimal residual disease negativity (MRD) prior to transplant by flow cytometry
• Event-free in patients who discontinue acalabrutinib at the point of MRD negativity prior to transplant by flow cytometry
• Changes in scores of partient reported outcomes (PRO) as measured by FACT-Lym
• Overall survival in patients who discontinue acalabrutinib at the point of MRD negativity
• Changes in scores of partient reported outcomes (PRO) as measured by FACT-Cog
• Changes in scores of partient reported outcomes (PRO) as measured by EORTC QLQ-C30

View this trial on ClinicalTrials.gov