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
Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 60
Healthy Volunteers: f
View:
• Histological confirmation of hematological malignancies
• Acute leukemias
• Acute Myeloid Leukemia (AML) and related precursor neoplasms
• Favorable risk AML is defined as having one of the following:
• Acute lymphoblastic leukemia (ALL)/lymphoma
• Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features.
• Age 60 years of age or younger at the time of consent
• Karnofsky performance status ≥ 70% or Lansky play score 50% for ≤16 years of age.
• Adequate organ function
Locations
United States
Minnesota
University of Minnesota Masonic Cancer Center
RECRUITING
Minneapolis
Contact Information
Primary
Margaret MacMillan
macmi002@umn.edu
612-626-2961
Time Frame
Start Date:2023-05-11
Estimated Completion Date:2030-11-30
Participants
Target number of participants:70
Treatments
Experimental: Arm 1A: Fludarabine (flu), Total Body Irradiation (TBI), Flu/TBI Regimen, Closed to Accrual
Patients will be treated on the most medically appropriate regimen with a preference for Flu/TBI Arm followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.
Experimental: Arm 2A: Fludarabine (flu), Busulfan (bu), Flu/Bu Regimen, Closed to Accrual
Patients will be treated on the most medically appropriate regimen with a preference for Flu/TBI Arm followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.
Experimental: Arm 3A: Fludarabine (flu), Busulfan (bu), Melphalan (Mel) Regimen for Pediatric Patients Only
Flu/Bu/Mel will the preference for patients with JMML or infants with leukemia. , Closed to Accrual
Experimental: Arm 1B: ATG, Fludarabine (flu), Total Body Irradiation (TBI), Flu/TBI Regimen
Patients will be treated on the most medically appropriate regimen with a preference for ATG/Flu/TBI Arm followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.
Experimental: Arm 2B: ATG, Fludarabine (flu), Busulfan (bu), Flu/Bu Regimen
Patients will be treated on the most medically appropriate regimen with a preference for ATG/Flu/BU/TBI Arm followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.
Experimental: Arm 3B: ATG, Fludarabine (flu), Busulfan (bu), Melphalan (Mel) Regimen for Pediatric Patients Only
ATG/Flu/Bu/Mel will the preference for patients with JMML or infants with leukemia.
Experimental: Arm 4B: ATG, Busulfan (BU), Cyclophosphamide (CY)
Patients will be treated on the most medically appropriate regimen with a preference for ATG/BU/CY Arm followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.
Experimental: Arm 5B: ATG, Cyclophosphamide (CY), Total Body Irradiation (TBI)
Patients will be treated on the most medically appropriate regimen with a preference for ATG/CY/TBI Arm followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.