Myelodysplastic Syndrome Clinical Trial
MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies
This is a phase II, open-label, prospective study of T cell receptor alpha/beta depletion (Î±/Î² TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies
Histological confirmation of hematological malignancies
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
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
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