MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies
NCT ID: NCT05735717
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
70 participants
INTERVENTIONAL
2023-05-11
2030-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Fludarabine
Fludarabine 25mg/m2 IV on days -8 to -6 or days -4 to -2. 40mg/m2 IV on days -5 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.
Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells
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.
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.
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
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.
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
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.
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.
Fludarabine
Fludarabine 25mg/m2 IV on days -8 to -6 or days -4 to -2. 40mg/m2 IV on days -5 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.
Thymoglobulin
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.
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.
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
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.
Thymoglobulin
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.
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.
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.
Thymoglobulin
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.
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.
Busulfan
Busulfan 82.1 mg\*hr/L IV on days -5 to -2 or days -8 to -5
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.
Thymoglobulin
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
Cyclophosphamide 60 mg/kg IV over 2 hours on days -3 and -2
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.
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.
Thymoglobulin
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
Cyclophosphamide 60 mg/kg IV over 2 hours on days -3 and -2
Interventions
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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.
Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells
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
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
Cyclophosphamide 60 mg/kg IV over 2 hours on days -3 and -2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Margaret MacMillan
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota Masonic Cancer Center
Locations
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University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Margaret MacMillan
Role: primary
Other Identifiers
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2021LS061
Identifier Type: -
Identifier Source: org_study_id
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