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MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies

StatusRecruiting
PhasePhase 2
Started2023-05-11
View on ClinicalTrials.gov ↗

Amendment history

2026-03-31
Study Status, Conditions v5
Re-verified, no change to tracked fields
2025-07-21
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures v4
Enrollment target150→70
Study arms3→8
InterventionsBusulfan (Drug), Fludarabine (Drug), Levetiracetam (Drug), Melphalan (Drug), Rituximab (Drug)→Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells (Biological), Busulfan (Drug), Cyclophosphamide (Drug), Fludarabine (Drug)…
2024-10-17
2 amendments v2-v3
2 re-verifications since 2023-10-02, no change to tracked fields
2023-05-12
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-04-09→confirmed 2023-05-11
Study sites0→1
2023-02-09
Original filing
This is a phase II, open-label, prospective study of T cell receptor alpha/beta depletion (TCR α/β TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies. This is a safety/feasibility study of the investigational procedure/product.
Trial Details
NCT Number NCT05735717
Lead Sponsor Masonic Cancer Center, University of Minnesota
Conditions Hematologic Malignancy, Acute Leukemia, Remission, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, AML, TP53, Intrachromosomal Amplification of Chromosome 21 +16 more
Enrollment 70 participants
Start Date 2023-05-11
Primary Completion 2027-11-30 (estimated)
Study Completion 2030-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-06