Acalabrutinib as Maintenance Therapy After Cellular Treatment for Patients Aged 18 to 70 with High-Risk Large B-Cell Lymphoma

What this Trial Is About

Researchers are studying the safety and effectiveness of maintenance treatment with acalabrutinib for patients who have large B-cell lymphoma and are at very high risk of the cancer returning after cellular therapy. This phase IbII trial aims to evaluate how well acalabrutinib works in preventing relapse, how long remission lasts after treatment, and survival rates. The study also looks at side effects and how the treatment affects immune cells and tumor DNA. Patients are assigned to one of three groups based on their prior cellular therapy those who had allogeneic hematopoietic cell transplantation begin acalabrutinib orally once daily from day 90 and then twice daily until day 365 those who had autologous stem cell transplantation start once daily from day 60 and then twice daily from day 74 until day 365 and patients who received CAR T-cell therapy begin twice daily treatment anytime between days 28 to 104 until day 365. Treatment continues unless the cancer progresses or side effects become unacceptable. Participants will be monitored regularly during the treatment period, with follow-up visits 30 days after completing the study drug. Researchers will track the need to stop the drug permanently, disease progression, survival, response rates, dose changes, and side effects including graft-versus-host disease and blood-related toxicities. The study lasts up to one year of treatment with long-term follow-up for up to five years to assess ongoing outcomes.

Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma