Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma

Mantle Cell Lymphoma Clinical Trial

Official title: Single Arm, Phase II Study of Acalabrutinib as Post-Autologous Blood or Marrow Transplant (BMT) Maintenance Therapy in Subjects With Mantle Cell Lymphoma

Status Completed

Clinical Trial Summary

This is a phase II study to evaluate efficacy of Acalabrutinib as a maintenance therapy following blood or marrow transplant (BMT) in patients who have been diagnosed with mantle cell lymphoma.

Clinical Trial Description

Mantle cell lymphoma (MCL) is one of approximately 100 different types of non-Hodgkin's lymphoma (NHL). Due to the aggressive and heterogeneous nature of MCL, majority of patients are diagnosed with advanced stage disease that requires immediate, diverse and aggressive courses of therapy to improve the outcome of the disease. The addition of blood or bone marrow transplantation (BMT) to the chemotherapy regimens is a critical factor to prolong duration of response in patients, however, the benefit of combination chemotherapy followed by BMT is often temporary as patients experience disease progression and mortality and this underscores the need for novel therapies as well as additional maintenance therapy strategies to prevent relapse post-BMT. Acalabrutinib, a selective, irreversible small molecule inhibitor of Bruton's tyrosine kinase (BTK) is approved for the treatment of adult patients with MCL who have received at least 1 prior therapy This study is a single arm, multi-center, phase 2 study of subjects who will receive acalabrutinib as maintenance therapy post-BMT. Subjects will undergo a standard of care BMT with conditioning regimen determined by the treating physician per institutional guidelines.The BMT is not considered part of this study. Following completion of the BMT, Maintenance therapy with acalabrutinib will begin on Day 100 in 28-day cycles. Subjects will self-administer 100 mg acalabrutinib BID until they reach 2 years post-BMT (approximately 22 cycles).Subjects will be followed for up to 5 years post-BMT for Progression Free Survival. ;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

• NCT number: NCT04402138
• Study type: Interventional
• Source: SCRI Development Innovations, LLC
• Status: Completed
• Phase: Phase 2
• Start date: August 7, 2020
• Completion date: April 5, 2024