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MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies
NCT05735717 · Masonic Cancer Center, University of Minnesota
In plain English
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Official title
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
About this 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.
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
Study design
Enrollment target: 70 participants
Allocation: non_randomized
Masking: none
Age groups: child, adult
Timeline
Starts: 2023-05-11
Estimated completion: 2030-11-30
Last updated: 2026-04-06
Interventions
Drug: FludarabineDrug: BusulfanDrug: MelphalanDrug: RituximabDrug: LevetiracetamBiological: Alpha/Beta T Cell-Depleted Hematopoietic Stem CellsDrug: ThymoglobulinDrug: Cyclophosphamide
Primary outcomes
- • Determine the rate of GVHD after alpha beta TCR depletion (100 days)
Sponsor
Masonic Cancer Center, University of Minnesota · other
Contacts & investigators
ContactMargaret MacMillan · contact · macmi002@umn.edu · 612-626-2961
InvestigatorMargaret MacMillan · principal_investigator, University of Minnesota Masonic Cancer Center
All locations (1)
University of Minnesota Masonic Cancer CenterRecruiting
Minneapolis, Minnesota, United States