NCT04402138

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 participants who will receive acalabrutinib as maintenance therapy post-BMT. Participants will undergo a standard of care BMT with conditioning regimen determined by the treating physician per institutional guidelines.The BMT procedure 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. Participants will self-administer 129 mg acalabrutinib twice daily (BID) until they reach 2 years post-BMT (approximately 22 cycles). Participants will be followed for up to 5 years post-BMT for Progression Free Survival.

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Acalabrutinib	Acalabrutinib 129 mg will be self-administered orally twice daily (BID) starting from 100 day (+/- 7 days) Post-BMT on a 28-day schedule, with or without food, until the patient has reached approximately 2 years post-BMT.

Timeline

• Start date: 2020-08-07
• Primary completion: 2024-04-05
• Completion: 2024-04-05
• First posted: 2020-05-26
• Last updated: 2025-05-13
• Results posted: 2025-05-13

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study