Acalabrutinib + R-CHOP for Mantle Cell Lymphoma
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you cannot participate if you need certain medications like strong CYP3A4 inhibitors/inducers, warfarin, or proton pump inhibitors. It's best to discuss your current medications with the study team to see if any adjustments are needed.
How is the drug Acalabrutinib + R-CHOP unique for treating mantle cell lymphoma?
The combination of Acalabrutinib with R-CHOP is unique because Acalabrutinib is a targeted therapy that specifically inhibits Bruton's tyrosine kinase (BTK), which plays a role in the growth of cancer cells, while R-CHOP is a chemotherapy regimen that attacks cancer cells in multiple ways. This combination aims to enhance treatment effectiveness by combining targeted and traditional chemotherapy approaches.12345
What is the purpose of this trial?
This trial tests if taking acalabrutinib with R-CHOP chemotherapy can help patients with untreated mantle cell lymphoma achieve remission before a stem cell transplant. Acalabrutinib blocks cancer growth, and R-CHOP kills cancer cells.
Eligibility Criteria
Adults with untreated mantle cell lymphoma eligible for R-CHOP chemotherapy and stem cell transplant can join this Canadian study. They must be able to swallow pills, understand the study risks, consent to it, and use effective birth control. Exclusions include central nervous system involvement, hypersensitivity to trial drugs, bleeding disorders, certain medication conflicts, recent major surgery or stroke, severe liver/kidney disease, other active cancers (with exceptions), significant heart issues, uncontrolled blood diseases like AIHA/ITP or live vaccinations recently.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive six cycles of R-CHOP chemotherapy together with continuous acalabrutinib
Response Assessment
Participants undergo response assessment with CT scan, PET/CT scan, and bone marrow biopsy
Stem Cell Mobilization and Transplantation
Responding patients proceed with stem cell mobilization, apheresis, and processing, followed by ASCT
Maintenance
Participants receive standard maintenance rituximab every 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Acalabrutinib
- R-CHOP chemotherapy
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?
University Health Network, Toronto
Lead Sponsor