MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies

Sponsor: Masonic Cancer Center, University of Minnesota

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05735717

Patient View

This phase II study evaluates α/β TCD PBSC transplantation in patients with confirmed hematological malignancies, including AML, ALL, and MDS. Eligible participants are ≤60 years old with adequate organ function. The regimen includes Fludarabine, Busulfan, Melphalan, Rituximab, and Levetiracetam to prevent seizures. Participants must have a performance status of ≥70% or a Lansky score of 50% for those ≤16 years.

Patient Parameters

Program Overview

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

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

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