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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT05735717
Phase
PHASE2
Status
Recruiting
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Conditions

  • AML
  • Acute Leukemia
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • CBL Gene Mutation
  • CNS Leukemia
  • Chromosome Abnormality
  • Cytogenetic Abnormality
  • Fetal Hemoglobin
  • Hematologic Malignancy
  • High Grade Non-Hodgkin's Lymphoma, Adult
  • Intrachromosomal Amplification of Chromosome 21
  • Juvenile Myelomonocytic Leukemia
  • Lymphoblastic Lymphoma
  • Minimal Residual Disease
  • Monosomy 7
  • Myelodysplasia
  • N-RAS Gene Amplification
  • NF1 Mutation
  • Neurofibromatosis 1
  • PTPN11 Gene Mutation
  • Remission
  • Somatic Mutation
  • TP53

Eligibility Criteria

Sex
ALL
Age
N/A - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    Fludarabine 25mg/m2 IV on days -8 to -6 or days -4 to -2. 40mg/m2 IV on days -5 to -2.
  • Busulfan — DRUG
    Busulfan 82.1 mg\*hr/L IV on days -5 to -2 or days -8 to -5
  • Melphalan — DRUG
    Melphalan 50 mg/m2 IV on days -4 to -2
  • Rituximab — DRUG
    200 mg/m2 intravenous given once on day-1
  • Levetiracetam — DRUG
    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.
  • Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells — BIOLOGICAL
    Patients will be treated on the most medically appropriate regimen followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.
  • Thymoglobulin — DRUG
    rabbit anti-thymocyte globulin (rATG). Used in conditioning regimens for in vivo depletion of T cells, and the use of fludarabine model-based dosing to optimize dosing.
  • Cyclophosphamide — DRUG
    Cyclophosphamide 60 mg/kg IV over 2 hours on days -3 and -2

Study Details

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.

Key Dates

Start date
May 11, 2023
Status verified
Mar 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2030

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1A: Fludarabine (flu), Total Body Irradiation (TBI), Flu/TBI Regimen, Closed to Accrual
    Patients will be treated on the most medically appropriate regimen with a preference for Flu/TBI Arm followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.
  • Experimental: Arm 2A: Fludarabine (flu), Busulfan (bu), Flu/Bu Regimen, Closed to Accrual
    Patients will be treated on the most medically appropriate regimen with a preference for Flu/TBI Arm followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.
  • Experimental: Arm 3A: Fludarabine (flu), Busulfan (bu), Melphalan (Mel) Regimen for Pediatric Patients Only
    Flu/Bu/Mel will the preference for patients with JMML or infants with leukemia. , Closed to Accrual
  • Experimental: Arm 1B: ATG, Fludarabine (flu), Total Body Irradiation (TBI), Flu/TBI Regimen
    Patients will be treated on the most medically appropriate regimen with a preference for ATG/Flu/TBI Arm followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.
  • Experimental: Arm 2B: ATG, Fludarabine (flu), Busulfan (bu), Flu/Bu Regimen
    Patients will be treated on the most medically appropriate regimen with a preference for ATG/Flu/BU/TBI Arm followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.
  • Experimental: Arm 3B: ATG, Fludarabine (flu), Busulfan (bu), Melphalan (Mel) Regimen for Pediatric Patients Only
    ATG/Flu/Bu/Mel will the preference for patients with JMML or infants with leukemia.
  • Experimental: Arm 4B: ATG, Busulfan (BU), Cyclophosphamide (CY)
    Patients will be treated on the most medically appropriate regimen with a preference for ATG/BU/CY Arm followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.
  • Experimental: Arm 5B: ATG, Cyclophosphamide (CY), Total Body Irradiation (TBI)
    Patients will be treated on the most medically appropriate regimen with a preference for ATG/CY/TBI Arm followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.

Primary Outcome Measure

Determine the rate of GVHD after alpha beta TCR depletion [ Time Frame: 100 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Minnesota Masonic Cancer CenterMinneapolisMinnesota55455
Margaret MacMillan

Find similar trials in Minneapolis, MN

By condition
Leukemia (other)
By specialty
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By research site
University of Minnesota Masonic Cancer Center· Minneapolis, MN

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