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This study evaluates a T-cell receptor alpha/beta-depleted peripheral blood stem cell transplant approach in patients with blood cancers (hematologic malignancies). It enrolls patients aged 60 and under with diagnoses such as acute leukemias or myelodysplasia and adequate organ function, using drugs such as Fludarabine, Busulfan, and Melphalan for preparation. It is being conducted in Phase 2 and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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