Clinical Trial

MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas

Study acronym: MALIBU
Active, Not Recruiting Phase 2
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Summary
Single-arm, phase II clinical trial of patients with Extranodal Marginal Zone Lymphoma (EMZL). It is planned to recruit 130 patients. Additional patients with Splenic Marginal Zone Lymphoma (SMZL), up to 30, and Nodal Marginal Zone Lymphoma (NMZL), up to 15, will be included in the trial in order to preliminary explore the clinical activity and safety of the combination treatment proposed. The study primary endpoints will be analysed on the EMZL population. Outcome of patients with SMZL and NMZL will be analysed and reported separately
Protocol Amendment History 20 amendments
This ClinicalTrials.gov record has been amended 20 times since 2018-10-03; most recent amendment 2026-04-07.
Status change: Recruiting → Active, Not Recruiting 2023-05-09
Status change: Not Yet Recruiting → Recruiting 2019-10-08
Trial Details
NCT Number NCT03697512
Lead Sponsor International Extranodal Lymphoma Study Group (IELSG)
Conditions Marginal Zone Lymphoma, Nodal Marginal Zone Lymphoma, Splenic Marginal Zone Lymphoma
Enrollment 175 participants
Start Date 2019-09-27
Primary Completion 2027-06-15 (estimated)
Study Completion 2027-06-15 (estimated)
Updated on ClinicalTrials.gov 2026-04-08