Clinical Trial

Genetically Risk-Stratified Venetoclax, Ibrutinib, Rituximab (± Navitoclax) in Relapsed/Refractory Mantle Cell Lymphoma

Active, Not Recruiting Phase 2
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Record status
This record was last updated August 12, 2024 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is an open label, multi-centre, phase II study in which RR MCL patients will be genetically risk-stratified into Standard risk (no 9p21.1-24.3 loss, no SMARCA2 or SMARCA4 mut/del) and High risk (9p21.1-24.3 loss, SMARCA2 and/or SMARCA4 mut/del). Patients without the high-risk mutations will be treated with ibrutinib, rituximab and venetoclax. Patients with the high-risk mutations will be treated with ibrutinib, rituximab, venetoclax and navitoclax.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-05-16; most recent amendment 2024-08-08.
Status change: Recruiting → Active, Not Recruiting 2024-08-08
Status change: Not Yet Recruiting → Recruiting 2023-09-26
Trial Details
NCT Number NCT05864742
Lead Sponsor Peter MacCallum Cancer Centre, Australia
Conditions Mantle Cell Lymphoma Refractory
Enrollment 40 participants
Start Date 2023-09-07
Primary Completion 2026-06-01 (estimated)
Study Completion 2029-06-01 (estimated)
Updated on ClinicalTrials.gov 2024-08-12