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
Masonic Cancer Center, University of Minnesota
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
- Age range
- Up to 60 years
- Sex
- All
- Healthy volunteers
- No
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. * Ad…
Interventions
- DrugFludarabine
Fludarabine 25mg/m2 IV on days -8 to -6 or days -4 to -2. 40mg/m2 IV on days -5 to -2.
- DrugBusulfan
Busulfan 82.1 mg\*hr/L IV on days -5 to -2 or days -8 to -5
- DrugMelphalan
Melphalan 50 mg/m2 IV on days -4 to -2
- DrugRituximab
200 mg/m2 intravenous given once on day-1
- DrugLevetiracetam
As seizures have occurred following high dose busulfan, all patients will be treated with Keppra beginning day -6 and continuing until day -1 per institutional guidelines.
- BiologicalAlpha/Beta T Cell-Depleted Hematopoietic Stem Cells
Patients will be treated on the most medically appropriate regimen followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.
Location
- University of Minnesota Masonic Cancer CenterMinneapolis, Minnesota