MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies
Study Details
Study Description
Brief 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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Fludarabine (flu), Total Body Irradiation (TBI), Flu/TBI Regimen 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. |
Drug: Fludarabine
Fludarabine 25mg/m2 IV on days -8 to -6 or days -4 to -2. 40mg/m2 IV on days -5 to -2.
Drug: Rituximab
200 mg/m2 intravenous given once on day-1
|
Experimental: Fludarabine (flu), Busulfan (bu), Flu/Bu Regimen 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. |
Drug: Fludarabine
Fludarabine 25mg/m2 IV on days -8 to -6 or days -4 to -2. 40mg/m2 IV on days -5 to -2.
Drug: Busulfan
Busulfan 82.1 mg*hr/L IV on days -5 to -2 or days -8 to -5
Drug: Rituximab
200 mg/m2 intravenous given once on day-1
Drug: 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.
Other Names:
|
Experimental: 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. |
Drug: Fludarabine
Fludarabine 25mg/m2 IV on days -8 to -6 or days -4 to -2. 40mg/m2 IV on days -5 to -2.
Drug: Busulfan
Busulfan 82.1 mg*hr/L IV on days -5 to -2 or days -8 to -5
Drug: Melphalan
Melphalan 50 mg/m2 IV on days -4 to -2
Drug: Rituximab
200 mg/m2 intravenous given once on day-1
Drug: 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Determine the rate of GVHD after alpha beta TCR depletion [85 months]
GVHD incidence after treatment.
Secondary Outcome Measures
- Transplant engraftment [42 days]
Monitor median rate of engraftment by 42 days.
- Graft Failure [100 days]
Determine the rate of graft failure by day 100 (defined as lack of achievement of an ANC >=500/mL with associated pancytopenia)
- Non-relapse mortality (NRM) [12 months]
Determine the incidence of non-relapse mortality (NRM) at 100 days and 1 year
- Overall survival (OS) [12 months]
Number of participants experiencing progression free survival at one year follow up
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histological confirmation of hematological malignancies
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Acute leukemias
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Acute Myeloid Leukemia (AML) and related precursor neoplasms
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Favorable risk AML is defined as having one of the following:
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Acute lymphoblastic leukemia (ALL)/lymphoma
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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.
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Age 60 years of age or younger at the time of consent
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Karnofsky performance status ≥ 70% or Lansky play score 50% for ≤16 years of age.
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Adequate organ function
Exclusion Criteria:
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Pregnant or breastfeeding.
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Active uncontrolled infection within 1 week of starting preparative therapy
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Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR.
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Any prior autologous or allogeneic transplant
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CML blast crisis
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Active central nervous system malignancy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Masonic Cancer Center, University of Minnesota
Investigators
- Principal Investigator: Najla El Jurdi, University of Minnesota Masonic Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021LS061