Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas

Status Recruiting

Clinical Trial Summary

This research is being done to assess the effectiveness and safety of acalabrutinib combined with lisocabtagene maraleucel (liso-cel) for people with relapsed/refractory aggressive B-cell lymphoma. This research study involves the study drug acalabrutinib in combination with lisocabtagene maraleuce

Clinical Trial Description

This research study involves the study drug acalabrutinib in combination with lisocabtagene maraleucel. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. - Participants will receive one infusion of liso-cel and will receive acalabrutinib capsules twice daily as long as treatment is tolerated and disease does not worsen (disease progression) for up to one year. Participants will be followed by clinical visits for up to 5 years and the medical record will be monitored for up to 15 years. It is expected that about 27 people will take part in this research study. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The U.S. Food and Drug Administration (FDA) has not approved acalabrutinib for this specific disease, but it has been approved for other uses. The U.S. FDA has approved lisocabtagene maraleucel for this specific disease. AstraZeneca, a pharmaceutical company, is supporting this research study by providing funding for the research study and supplying acalabrutinib. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05583149
Study type	Interventional
Source	Massachusetts General Hospital
Contact	Connor Johnson, MD
Phone	(617)-724-4000
Email	pcjohnson@mgh.harvard.edu
Status	Recruiting
Phase	Phase 2
Start date	March 1, 2023
Completion date	March 1, 2029

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