Acalabrutinib in Combination With R-CHOP for Previously Untreated Diffuse Large B-cell Lymphoma (DLBCL)
Status:
Recruiting
Trial end date:
2026-03-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust