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Not Yet Recruiting
NCT05735717
MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies
Conditions: Hematologic Malignancy, Acute Leukemia, Remission, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, AML, TP53, Intrachromosomal Amplification of Chromosome 21, Cytogenetic Abnormality, CNS Leukemia, Minimal Residual Disease, Myelodysplasia, Juvenile Myelomonocytic Leukemia, Somatic Mutation, PTPN11 Gene Mutation, N-RAS Gene Amplification, Neurofibromatosis 1, NF1 Mutation, CBL Gene Mutation, Monosomy 7, Chromosome Abnormality, Fetal Hemoglobin
Sex: All
Ages: N/A – 60 Years
Phase: PHASE2
Enrollment: 150
Sponsor: Masonic Cancer Center, University of Minnesota
Summary
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 malignanciesAcute leukemiasAcute Myeloid Leukemia (AML) and related precursor neoplasmsFavorable risk AML is defined as having one of the following:Acute lymphoblastic leukemia (ALL)/lymphomaMyelodysplasia (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 consentKarnofsky performance status ≥ 70% or Lansky play score 50% for ≤16 years of age.Adequate organ functionExclusion Criteria:Pregnant or breastfeeding.Active uncontrolled infection within 1 week of starting preparative therapyKnown seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR.Any prior autologous or allogeneic transplantCML blast crisisActive central nervous system malignancy
Source: ClinicalTrials.gov (NCT05735717). StuddyBuddy aggregates publicly available trial information.
