Clinical Trial

Study of Ibrutinib + CD20 Antibody and Venetoclax in Patients With Untreated Mantle Cell Lymphoma

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The OASIS II trial is a multicentre, open label, randomized phase II trial. We will compare the efficacy of Ibrutinib/anti-CD20 Ab versus Ibrutinib/anti-CD20 Ab/Venetoclax given as fixed duration combinations in newly diagnosed Mantle Cell Lymphoma (MCL) patients (≥ 18 years and \< 80 years of age). Treatment duration of Ibrutinib and Venetoclax will be a maximum of two years. Patients will be treated with CD20 Ab for 3.5 years. The primary aim is to assess MRD status at 6 months in both arms.
Protocol Amendment History 1 change
notable Primary completion pushed: 2026-03-31 -> 2028-03-31 2026-05-21
Trial Details
NCT Number NCT04802590
Lead Sponsor The Lymphoma Academic Research Organisation
Collaborators: Institute of Cancer Research, United Kingdom
Conditions Mantle Cell Lymphoma
Enrollment 210 participants
Start Date 2022-01-24
Primary Completion 2028-03-31 (estimated)
Study Completion 2031-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-20