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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

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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