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RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the side effects of donor peripheral stem cell transplant and to see how well it works in treating patients with acute lymphoblastic leukemia.
- Determine the 1-year disease-free survival of patients with acute lymphoblastic leukemia in complete remission treated with nonmyeloablative allogeneic peripheral blood stem cell transplantation from HLA-matched unrelated donors.
- Determine the day 200 transplant-related mortality in patients treated with this regimen.
- Determine the efficacy of donor lymphocyte infusions (DLI) in patients treated with this regimen.
- Determine the toxicity of DLI in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive fludarabine IV on days -4 to -2. Patients undergo total body irradiation on day 0 followed by allogeneic peripheral blood stem cell infusion. Patients also receive oral cyclosporine twice daily on days -3 to 100 with a taper from day 101-177 and oral mycophenolate mofetil 3 times daily on days 0-40 with a taper from day 41-96.
Beginning 1-2 weeks after withdrawal of immunosuppression, patients with no evidence of acute graft-vs-host disease grade 2 or greater and no morphological disease progression may receive up to 3 donor lymphocyte infusions (DLI) IV over 30 minutes.
Patients are followed monthly for 4 months, at 6, 12, 18, and 24 months, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 30 patients (20 adults and 10 children) will be accrued for this study within 2 years.
Masking: Open Label, Primary Purpose: Treatment
therapeutic allogeneic lymphocytes, cyclosporine, fludarabine phosphate, mycophenolate mofetil, peripheral blood stem cell transplantation, radiation therapy
Cancer Institute at Oregon Health and Science University
Fred Hutchinson Cancer Research Center
Published on BioPortfolio: 2014-08-27T03:56:19-0400
RATIONALE: Peripheral stem cell or bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Someti...
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells. Sometimes the trans...
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells can make an ...
Alemtuzumab Plus Fludarabine and Melphalan With or Without Cyclosporine, Mycophenolate Mofetil, and Low-Dose Total-Body Irradiation Therapy Followed by Donor Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer
RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It als...
RATIONALE: Peripheral stem cell or bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cel...
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The combination of calcineurin inhibitor (CNI) such as tacrolimus (TAC) or cyclosporine (CYSP) with methotrexate (MTX) or with mycophenolate mofetil (MMF) has been commonly used for Graft-versus-Host ...
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