Acalabrutinib + Chemotherapy for Mantle Cell Lymphoma
Trial Summary
What is the purpose of this trial?
This study is designed to evaluate the efficacy and safety of acalabrutinib plus bendamustine and rituximab followed by acalabrutinib plus cytarabine and rituximab in subjects with treatment naïve mantle cell lymphoma (MCL), as a preparation for a larger cooperative group trial with the goal of achieving a standard induction regimen for MCL in transplant eligible patients. The investigators hypothesize that the addition of acalabrutinib to BR/CR regimen will prove safe and increase the complete response (CR) rate as well as minimal residual disease (MRD) negativity pre-transplant, thus improving clinical outcomes.
Research Team
Brad S. Kahl
Principal Investigator
Washington University School of Medicine
Eligibility Criteria
This trial is for adults aged 18-70 with untreated mantle cell lymphoma who are eligible for stem cell transplantation. Participants must have adequate organ and bone marrow function, no history of significant bleeding disorders or major surgery within the last month, and not be on certain medications like strong CYP3A4 inhibitors or proton pump inhibitors. Pregnant or breastfeeding women cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive acalabrutinib plus bendamustine and rituximab for Cycles 1-3, followed by acalabrutinib plus cytarabine and rituximab for Cycles 4-6
Leukapheresis
Patients undergo leukapheresis after completion of Cycle 6
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for progression-free survival and overall survival
Treatment Details
Interventions
- Acalabrutinib
- Bendamustine
- Cytarabine
- Rituximab
Acalabrutinib is already approved in United States, European Union for the following indications:
- Mantle cell lymphoma
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma
- Mantle cell lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Acerta Pharma BV
Industry Sponsor