Conditioning for Hematopoietic Stem Cell Transplantation With Fludarabine Plus Targeted IV Busulfan and GVHD Prophylaxis With Thymoglobulin, Tacrolimus and Methotrexate in 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.
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
Incidence and severity of acute GvHD
Determined by LTFU.
Day 100 post-transplant
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|