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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05735717
Other study ID # 2021LS061
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 11, 2023
Est. completion date November 30, 2030

Study information

Verified date October 2023
Source Masonic Cancer Center, University of Minnesota
Contact Margaret MacMillan
Phone 612-626-2961
Email macmi002@umn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date November 30, 2030
Est. primary completion date November 30, 2027
Accepts healthy volunteers No
Gender All
Age group N/A to 60 Years
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 Design


Related Conditions & MeSH terms

  • Acute Leukemia
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • AML
  • Chromosome Aberrations
  • Chromosome Abnormality
  • Chromosome Disorders
  • Congenital Abnormalities
  • Cytogenetic Abnormality
  • Fetal Hemoglobin
  • Hematologic Malignancy
  • Hematologic Neoplasms
  • Juvenile Myelomonocytic Leukemia
  • Leukemia
  • Leukemia, Myelomonocytic, Juvenile
  • Minimal Residual Disease
  • Monosomy 7
  • Myelodysplasia
  • Neoplasm, Residual
  • Neoplasms
  • Neurofibromatoses
  • Neurofibromatosis 1
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Remission
  • Somatic Mutation
  • TP53

Intervention

Drug:
Fludarabine
Fludarabine 25mg/m2 IV on days -8 to -6 or days -4 to -2. 40mg/m2 IV on days -5 to -2.
Busulfan
Busulfan 82.1 mg*hr/L IV on days -5 to -2 or days -8 to -5
Melphalan
Melphalan 50 mg/m2 IV on days -4 to -2
Rituximab
200 mg/m2 intravenous given once on day-1
Levetiracetam
As seizures have occurred following high dose busulfan, all patients will be treated with Keppra beginning day -6 and continuing until day -1 per institutional guidelines.

Locations

Country Name City State
United States University of Minnesota Masonic Cancer Center Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine the rate of GVHD after alpha beta TCR depletion GVHD incidence after treatment. 85 months
Secondary Transplant engraftment Monitor median rate of engraftment by 42 days. 42 days
Secondary Graft Failure Determine the rate of graft failure by day 100 (defined as lack of achievement of an ANC >=500/mL with associated pancytopenia) 100 days
Secondary Non-relapse mortality (NRM) Determine the incidence of non-relapse mortality (NRM) at 100 days and 1 year 12 months
Secondary Overall survival (OS) Number of participants experiencing progression free survival at one year follow up 12 months
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