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About
This phase II trial studies how well total-body irradiation, donor lymphocyte infusion, and cyclophosphamide before donor stem cell transplant works in treating patients with high-risk hematologic malignancies. Giving total-body irradiation, donor lymphocyte infusion, and chemotherapy before a donor stem cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing the T cells from the donor cells before transplant and giving tacrolimus and mycophenolate mofetil may stop this from happening.
Full description
PRIMARY OBJECTIVES:
SECONDARY OBJECTIVES:
OUTLINE:
CONDITIONING REGIMEN: Patients undergo TBI twice daily (BID) on days -10 to -8, undergo DLI on day -6, and receive cyclophosphamide intravenously (IV) over 2 hours on days -3 and -2.
TRANSPLANT: Patients undergo cluster of differentiation (CD) 34+ selected allogeneic HSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV or orally (PO) beginning on day -1 with taper beginning by day 42, and mycophenolate mofetil IV BID on days -1 to 28.
After completion of study treatment, patients are followed up for 1 year.
Enrollment
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Inclusion criteria
This treatment is for patients with high risk hematologic malignancies. High risk is defined as:
Patients must have one related donor who is HLA (human leukocyte antigen) mismatched in the GVHD direction at two or more HLA loci
Patients must adequate organ function:
Karnofsky Performance Status (KPS) of > 80% on the modified (KPS) tool
Patients must be willing to use contraception if they have childbearing potential
Able to give informed consent
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41 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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