MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies
Hematologic Malignancy, Acute Leukemia, Remission
About this trial
This is an interventional treatment trial for Hematologic Malignancy focused on measuring Bu, Flu, G-CSF, GFSR, aGVHD, HCT, MAC, Mel, PBSCT, PTLD, RECIST, TCR
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Pregnant or breastfeeding. Active uncontrolled infection within 1 week of starting preparative therapy Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR. Any prior autologous or allogeneic transplant CML blast crisis Active central nervous system malignancy
Sites / Locations
- University of Minnesota Masonic Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Fludarabine (flu), Total Body Irradiation (TBI), Flu/TBI Regimen
Fludarabine (flu), Busulfan (bu), Flu/Bu Regimen
Fludarabine (flu), Busulfan (bu), Melphalan (Mel) Regimen for Pediatric Patients Only
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.
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.
Flu/Bu/Mel will the preference for patients with JMML or infants with leukemia.