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Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL

StatusRecruiting
PhasePhase 2
Started2024-08-23
View on ClinicalTrials.gov ↗

Amendment history

2026-03-30
4 amendments v5-v8
4 re-verifications since 2025-08-25, no change to tracked fields
2025-05-12
Study Status, Contacts/Locations v4
Study sitesdetails revised at 1 of 3 sites
2025-04-16
2 amendments v2-v3
2 re-verifications since 2025-01-22, no change to tracked fields
2024-09-03
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-08→confirmed 2024-08-23
Study sitesdetails revised at 3 of 3 sites
2024-08-12
Original filing
This is a phase 2, open-label, randomized, multicenter clinical trial in patients with relapsed/refractory mantle cell lymphoma (R/R MCL) who meet the criteria for standard-of-care FDA label for CD19 CAR T-cell therapy with brexucabtagene autoleucel (brexu-cel).
Trial Details
NCT Number NCT06553872
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Bankhead-Coley Florida Biomedical Research Program, Eli Lilly and Company
Conditions Mantle Cell Lymphoma
Enrollment 60 participants
Start Date 2024-08-23
Primary Completion 2029-08 (estimated)
Study Completion 2029-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-23