Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Mantle-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Mantle Cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Acalabrutinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Acalabrutinib will be self-administered orally for up to approximately 2 years post-BMT.

Acalabrutinib 100 mg BID will be self-administered orally 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.

Michael Tees, MD

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.

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.

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

Progression Free Survival Rate is defined as the number of subjects who are alive and free of disease progression or relapse according to RECIL for up to 2 years post-BMT.

According to RECIL, disease progression is defined as following criteria:

* \>20% increase in sum of longest diameters of target lesions.
* For small lymph nodes measuring \<15 mm post therapy, a minimum absolute increase of 5 mm and the longest diameter should exceed 15mm.
* Appearance of new lesions

Proportion of patients whose whole blood and bone marrow results transition from MRD positive to MRD negative during therapy for up to 2 years post-BMT.

An MRD Negative status will be defined as all results from whole blood and BM that are negative for the presence of residual clonal cells (with assay sensitivity of 10\^-6) per Adaptive Biotechnologies' reporting methods.

To compare the median PFS for MRD negative population with MRD positive population

Number of Participants with grade 3,4 or 5 Adverse events/Serious Adverse events

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma	NCT04402138	Mantle Cell Lym...	Acalabrutinib	18 Years -	SCRI Development Innovations, LLC
Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma	NCT04402138	Mantle Cell Lym...	Acalabrutinib	18 Years -	SCRI Development Innovations, LLC
Treatment With Acalabrutinib Post Blood or Marrow Transplantation in Subjects With Mantle Cell Lymphoma	NCT04402138	Mantle Cell Lym...	Acalabrutinib	18 Years -	SCRI Development Innovations, LLC

Spots Global Cancer Trial Database for blood or marrow transplant