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Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)

StatusRecruiting
PhasePhase 2
Started2023-12-26
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 32 months later Nov 15, 2028 → Jul 29, 2031
See other at-risk trials from H. Lee Moffitt Cancer Center and Research Institute

Amendment history

2026-09-26
Primary completion pushed: 2028-11-15 → 2031-07-29
Completion pushed: 2028-11-15 → 2031-07-29
2026-03-30
3 amendments v9-v11
3 re-verifications since 2025-11-12, no change to tracked fields
2025-08-25
Study Status, Contacts/Locations v8
Study sitescontacts updated at 1 of 1 site
2025-04-16
5 amendments v3-v7
5 re-verifications since 2024-02-07, no change to tracked fields
2024-02-02
Study Status v2
Start date2023-11-15→2023-12-26
2023-11-28
Study Status, Outcome Measures v1
Primary completion date2026-11-15→2028-11-15
Secondary endpointsdetails revised at 2 of 8 entries
2023-11-16
Original filing
This is a Phase 2 Study is to determine the efficacy and safety rate of B-Cell Acute Lymphoblastic Leukemia (B-ALL) participants in remission with minimal residual disease (MRD) after KTE-X19 CAR T-cell therapy
Trial Details
NCT Number NCT06144606
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Kite, A Gilead Company
Conditions B-Cell Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia
Enrollment 60 participants
Start Date 2023-12-26
Primary Completion 2031-07-29 (estimated)
Study Completion 2031-07-29 (estimated)
Updated on ClinicalTrials.gov 2026-09-25