Unrelated Donor Hematopoietic Stem Cell Transplantation After Nonmyeloablative Conditioning For Patients With Hematological Malignancies
OBJECTIVES:
- To investigate whether unrelated donor hematopoietic stem cell transplantation using a
nonmyeloablative conditioning regimen comprising busulfan, fludarabine phosphate, and
anti-thymocyte globulin can reduce treatment-related mortality in patients with
hematologic malignancies.
- To investigate whether this regimen can be sufficiently immunosuppressive to enable
engraftment of HLA-matched unrelated hematopoietic stem cells.
OUTLINE: This is a multicenter study.
Prior to receiving the conditioning chemotherapy regimen, all patients with acute leukemia,
chronic myelogenous leukemia (CML), and high-risk myelodysplastic syndromes (chronic
myelomonocytic leukemia, atypical CML, and refractory anemia with excess blasts) receive one
dose of intrathecal (IT) methotrexate. These patients also receive leucovorin calcium IV or
orally 4 hours after IT methotrexate and every 6 hours for a total of 8 doses.
- Nonmyeloablative conditioning regimen: Patients receive fludarabine phosphate IV over
30 minutes on days -7 to -2, busulfan IV over 3 hours on days -7 to -6, anti-thymocyte
globulin IV over 4 hours on days -4 to -2.
- Allogeneic bone marrow stem cell transplantation (SCT): Patients undergo allogeneic
bone marrow SCT on day 0.
- Graft-versus-host-disease (GVHD) prophylaxis: Patients receive cyclosporine (CSA) IV
over 2-4 hours every 12 hours starting on day -1 and continuing until day 180 (CSA can
be given orally every 12 hours once oral medication can be tolerated) and methotrexate
IV on days 1, 3 , 6 , and 11.
Once blood counts recover, patients with acute leukemia or CML in blast crisis resume IT
methotrexate once every 2 weeks for a total of 3 doses. Patients also receive leucovorin
calcium IV or orally 4 hours after IT methotrexate and then every 6 hours for a total of 8
doses.
Patients are followed for at least 10 years after SCT.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Treatment-related mortality
Yes
Kyoo H. Lee, MD
Study Chair
Asan Medical Center
United States: Federal Government
CDR0000583220
NCT00627666
January 2003
June 2010
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