A Multi-Center Study of Conditioning With Treosulfan, Fludarabine and Escalating Doses of TBI for Allogeneic Hematopoietic Cell Transplantation in Patients With Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome (MDS), and Acute Lymphoblastic Leukemia (ALL)
I. Decrease the incidence of relapse to < 15% at 6 month post transplant in patients with
high risk acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) transplanted from
related or unrelated donors, without unacceptably increasing toxicity (10% non-relapse
mortality [NRM] at 6 months).
I. Evaluate the incidence of NRM at 180 days and 1 year after hematopoietic cell
II. Evaluate overall survival (OS) and relapse-free survival (RFS). III. Incidence of grades
II-IV acute graft-versus-host disease (GVHD). IV. Incidence of chronic GVHD. V. Donor
chimerism on days +28 and +100.
CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) over 30
minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients
also undergo total-body irradiation on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or
bone marrow transplantation on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally (PO) twice daily
(BID) on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients
also receive methotrexate IV on days 1, 3, 6, and 11.
After completion of study treatment, patients are followed up periodically.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Relapse incidence to < 15%
At 6 months
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|University of Colorado||Denver, Colorado 80217|
|Oregon Health and Science University||Portland, Oregon 97201|