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

First listed
Feb 21, 2023
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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