NCT05735717PHASE2Recruiting
MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies
Masonic Cancer Center, University of Minnesota
Start Date
5/11/2023
Completion Date
11/30/2030
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 Criteria
Age Range: No minimum to 60 years
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
Interventions
DRUG
Fludarabine
DRUG
Busulfan
DRUG
Melphalan
DRUG
Rituximab
DRUG
Levetiracetam
BIOLOGICAL
Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells
DRUG
Thymoglobulin
DRUG
Cyclophosphamide
Conditions
Hematologic MalignancyAcute LeukemiaRemissionAcute Myeloid LeukemiaAcute Lymphoblastic LeukemiaAMLTP53Intrachromosomal Amplification of Chromosome 21Cytogenetic AbnormalityCNS LeukemiaMinimal Residual DiseaseMyelodysplasiaJuvenile Myelomonocytic LeukemiaSomatic MutationPTPN11 Gene MutationN-RAS Gene AmplificationNeurofibromatosis 1NF1 MutationCBL Gene MutationMonosomy 7Chromosome AbnormalityFetal HemoglobinLymphoblastic LymphomaHigh Grade Non-Hodgkin's Lymphoma, Adult
Locations
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota 55455
United States