Overview
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
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