Acalabrutinib in Combination With R-CHOP for Previously Untreated Diffuse Large B-cell Lymphoma (DLBCL)

This study evaluates the addition of Acalabrutinib to current standard therapy of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone (R-CHOP) for patients with previously untreated CD20 positive Diffuse Large B-cell Lymphoma (DLBCL) requiring full course chemoimmunotherapy. All patients will receive one cycle of R-CHOP. Two thirds of patients (Arm B) will go on to receive a further 5 cycles (every 21 days) of R-CHOP with Acalabrutinib. Acalabrutinib will be taken orally twice daily continuously in 21 day cycles. One third of patients (Arm A) will continue with 5 cycles of R-CHOP. Patients will be followed up initially for 24 months and then for disease status and survival until 114 progression events have been observed.

NCT Number	NCT04546620
Lead Sponsor	University Hospital Southampton NHS Foundation Trust Collaborators: AstraZeneca
Conditions	Diffuse Large B Cell Lymphoma
Enrollment	453 participants
Start Date	2021-10-19
Primary Completion	2027-11 (estimated)
Study Completion	2028-05 (estimated)
Updated on ClinicalTrials.gov	2026-04-30