Actively Recruiting
Phase 2 Study of Acalabrutinib and Rituximab for Untreated Elderly or Frail Patients With Diffuse Large B-Cell Lymphoma
Led by AstraZeneca · Updated on 2026-08-06
80
Participants Needed
57
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of acalabrutinib combined with rituximab in elderly andor frail patients with diffuse large B-cell lymphoma DLBCL who have not received prior treatment and are unsuitable for standard chemotherapy. This Phase II study focuses on patients aged 65 and older, aiming to find treatment options for those who cannot undergo usual frontline chemoimmunotherapy. Participants will receive oral acalabrutinib starting on Cycle 1 Day 1 for up to 28 cycles or until disease progression or other reasons for stopping. Additionally, rituximab will be given intravenously on Cycle 1 Day 15, followed by subcutaneous injections from Cycle 2 Day 1 through Cycle 8. The study involves a single treatment arm with this combination therapy. Each participant will be involved for up to 108 weeks, including up to 28 days for screening and 104 weeks for treatment and follow-up. Researchers will assess adverse events, objective response rate, progression-free survival, overall survival, and functional mobility using the Timed Up and Go test. Safety monitoring continues throughout the study, including up to 30 days after treatment ends, to evaluate treatment-emergent adverse events and long-term outcomes.
CONDITIONS
Brief Title
Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL
Research Team
A
AstraZeneca Clinical Study Information Center
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