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RATIONALE: Giving chemotherapy, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy 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 T cells from the donor cells before transplant and giving cyclosporine or tacrolimus before and after transplant may stop this from happening. Giving an infusion of the donor's T cells (donor lymphocyte infusion) later may help the patient's immune system see any remaining cancer or abnormal cells as not belonging to the patient's body and destroy them (graft-versus-tumor effect).
PURPOSE: This phase II trial is studying how well a donor peripheral blood stem cell transplant works in treating patients with hematologic cancer or other disease.
- Determine the overall survival rate at day 200 in patients with hematologic cancers or other diseases who undergo allogeneic peripheral blood stem cell transplantation using the CliniMACS® CD34 Reagent System for T-cell depletion followed by delayed T-cell add-back.
- Determine the safety of this regimen, in terms of the nonrelapse mortality rate at day 200, in these patients.
- Myeloablative preparative regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -8 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Patients also undergo high-dose* total body irradiation (TBI) twice daily on days -7 to -4.
NOTE: *Patients over 55 years of age receive reduced-dose TBI.
- Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients receive T-cell-depleted (via the CliniMACS® CD34 Reagent System), filgrastim (G-CSF)-mobilized, donor PBSC IV over 4 hours on day 0.
- Graft-versus-host-disease (GVHD) prophylaxis: Patients receive cyclosporine (or tacrolimus) IV or orally twice daily on days -6 to 21, and then again beginning on day 89 and continuing up to day 150, followed by a slow taper to day 180, in the absence of GVHD.
- Donor lymphocyte infusion (DLI): Patients receive delayed T-cell add-backs of donor lymphocytes IV over 1 hour on day 90. If relapse occurs, patients may receive DLI before day 90 or as a repeat infusion.
After completion of study therapy, patients are followed periodically for 3 years.
Masking: Open Label, Primary Purpose: Treatment
Chronic Myeloproliferative Disorders
therapeutic allogeneic lymphocytes, cyclophosphamide, cyclosporine, fludarabine phosphate, tacrolimus, allogeneic hematopoietic stem cell transplantation, in vitro-treated peripheral blood stem cell transplantation, peripheral blood stem cell transplantat
NIH - Warren Grant Magnuson Clinical Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:41:38-0400
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A family of immunophilin proteins that bind to the immunosuppressive drugs TACROLIMUS (also known as FK506) and SIROLIMUS. EC 5.2.1.-
A cyclic undecapeptide from an extract of soil fungi. It is a powerful immunosupressant with a specific action on T-lymphocytes. It is used for the prophylaxis of graft rejection in organ and tissue transplantation. (From Martindale, The Extra Pharmacopoeia, 30th ed).
A macrolide isolated from the culture broth of a strain of Streptomyces tsukubaensis that has strong immunosuppressive activity in vivo and prevents the activation of T-lymphocytes in response to antigenic or mitogenic stimulation in vitro.
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