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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


Description

This is a phase II, open-label, prospective study of T cell receptor alpha/beta depletion (α/β TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies

Trial Eligibility

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 Info

Organization

Masonic Cancer Center, University of Minnesota


Primary Outcome

Determine the rate of GVHD after alpha beta TCR depletion


Outcome Timeframe 85 months

NCTID NCT05735717

Phases PHASE2

Primary Purpose TREATMENT

Start Date 2023-05-11

Completion Date 2027-11-30

Enrollment Target 150

Interventions

DRUG Fludarabine

DRUG Busulfan

DRUG Melphalan

DRUG Rituximab

DRUG Levetiracetam

Locations Recruiting

University of Minnesota Masonic Cancer Center

United States, Minnesota, Minneapolis


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