MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies
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
70 participants
May 11, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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 Criteria6
- 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
Interventions
Fludarabine 25mg/m2 IV on days -8 to -6 or days -4 to -2. 40mg/m2 IV on days -5 to -2.
Busulfan 82.1 mg\*hr/L IV on days -5 to -2 or days -8 to -5
Melphalan 50 mg/m2 IV on days -4 to -2
200 mg/m2 intravenous given once on day-1
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.
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.
rabbit anti-thymocyte globulin (rATG). Used in conditioning regimens for in vivo depletion of T cells, and the use of fludarabine model-based dosing to optimize dosing.
Cyclophosphamide 60 mg/kg IV over 2 hours on days -3 and -2
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05735717