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MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies
Sponsor: Masonic Cancer Center, University of Minnesota
Summary
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.
Official title: Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults With Hematological Malignancies
Key Details
Gender
All
Age Range
Any - 60 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2023-05-11
Completion Date
2030-11-30
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Fludarabine
Fludarabine 25mg/m2 IV on days -8 to -6 or days -4 to -2. 40mg/m2 IV on days -5 to -2.
Busulfan
Busulfan 82.1 mg\*hr/L IV on days -5 to -2 or days -8 to -5
Melphalan
Melphalan 50 mg/m2 IV on days -4 to -2
Rituximab
200 mg/m2 intravenous given once on day-1
Levetiracetam
As seizures have occurred following high dose busulfan, all patients will be treated with Keppra beginning day -6 and continuing until day -1 per institutional guidelines.
Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells
Patients will be treated on the most medically appropriate regimen followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.
Thymoglobulin
rabbit anti-thymocyte globulin (rATG). Used in conditioning regimens for in vivo depletion of T cells, and the use of fludarabine model-based dosing to optimize dosing.
Cyclophosphamide
Cyclophosphamide 60 mg/kg IV over 2 hours on days -3 and -2
Locations (1)
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States