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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
Who can join
Up to age 60 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Fludarabine (drug)
- Busulfan (drug)
- Melphalan (drug)
- Rituximab (drug)
- Levetiracetam (drug)
- Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells (biological)
Sponsor: Masonic Cancer Center, University of Minnesota · Participants: 70 · Started: May 11, 2023
Contact the study team
- Margaret MacMillan · Phone: 612-626-2961
Official record on ClinicalTrials.gov — NCT05735717
Locations in the U.S.
| Minnesota | University of Minnesota Masonic Cancer Center, Minneapolis |
Conditions
- Blood Cancers
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- with Excess of Blasts Refractory Anemia
- Juvenile Myelomonocytic Leukemia
- beta-Thalassemia
- Flu
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.