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RATIONALE: Giving chemotherapy, such as fludarabine phosphate and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also 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. Giving anti-thymocyte globulin before transplant and tacrolimus and methotrexate after transplant may stop this from happening.
PURPOSE: This phase II trial is studying the side effects and how well giving fludarabine phosphate, busulfan, anti-thymocyte globulin followed by donor peripheral blood stem cell transplant, tacrolimus, and methotrexate works in treating patients with myeloid malignancies.
I. Determine the incidence and severity of acute GvHD.
I. Determine the pharmacokinetics of IV busulfan including interdose variability and evaluation of a limited sampling strategy.
II. Determine thymoglobulin pharmacokinetics. III. Determine the incidence of donor engraftment. IV. Determine system toxicities >= Grade 3 per CTCAE v.3. V. Determine the incidence and severity of chronic GvHD. VI. Determine the incidence of non-relapse mortality at Day +100 and at 1 yr. VII. Determine the incidence of relapse. VIII. Determine relapse-free survival. IX. Determine the incidence of EBV activation.
OUTLINE: Patients receive fludarabine phosphate IV over 30 minutes on days -9 to -6, busulfan IV over 3 hours on days -5 to -2, and anti-thymocyte globulin IV over 6 hours on days -3 and -2 and over 4 hours on day -1. Patients undergo donor peripheral blood stem cell transplant on day 0. Patients then receive tacrolimus IV continuously or orally every 12 hours beginning on day -1 and taper to day 180 and methotrexate IV on days 1, 3, 6, and 11.
After completion of study treatment, patients are followed at 1 year.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
fludarabine phosphate, busulfan, anti-thymocyte globulin, tacrolimus, methotrexate, peripheral blood stem cell transplantation, allogeneic hematopoietic stem cell transplantation
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Published on BioPortfolio: 2014-08-27T03:16:22-0400
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A 12-KDa tacrolimus binding protein that is found associated with and may modulate the function of calcium release channels. It is a peptidyl-prolyl cis/trans isomerase which is inhibited by both tacrolimus (commonly called FK506) and SIROLIMUS.
An alkylating agent having a selective immunosuppressive effect on BONE MARROW. It has been used in the palliative treatment of chronic myeloid leukemia (MYELOID LEUKEMIA, CHRONIC), but although symptomatic relief is provided, no permanent remission is brought about. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), busulfan is listed as a known carcinogen.
A family of immunophilin proteins that bind to the immunosuppressive drugs TACROLIMUS (also known as FK506) and SIROLIMUS. EC 5.2.1.-
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A serine threonine kinase that controls a wide range of growth-related cellular processes. The protein is referred to as the target of RAPAMYCIN due to the discovery that TACROLIMUS (commonly known as rapamycin) forms an inhibitory complex with TACROLIMUS BINDING PROTEIN 1A that blocks the action of its enzymatic activity.
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