Azacitidine Maintenance Therapy After Allogeneic Bone Marrow Transplantation (Allo BMT)
Myelodysplastic Syndrome, Leukemia
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Allogeneic Transplantation, Leukemia, Azacitidine, Vidaza
Eligibility Criteria
Inclusion Criteria: Patients with a diagnosis of AML (WHO classification: >=20% blasts in the bone marrow and / or peripheral blood), or MDS (IPSS intermediate-2 or higher) that at the time of allogeneic transplantation were in. Induction Failure, relapsed disease or second or greater remission. Patients in first complete remission that required more than 2 cycles of treatment to achieve the remission. Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch) Age 18 to 75 years and Left ventricular ejection fraction >40% and FEV1, FVC and DLCO >40% and Serum creatinine <1.6 mg/dL and Serum bilirubin < 1.6 mg/dL and SGPT < 3 X upper limit of normal and All patients and donors or guardian should be able to understand and sign informed consent. Women of childbearing potential (any female who has experienced menarche, and who has not undergone surgical sterilization or is not post-menopausal) must have a negative serum pregnancy test. Exclusion Criteria: HIV positive AML or MDS in first complete remission (defined as: bone marrow with less than 6% blasts, no circulating blasts, and a platelet count greater than 100,000 /mm^3.) Active uncontrolled infection Pregnancy or breastfeeding
Sites / Locations
- UT MD Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Azacitidine
Azacitidine after Allogeneic Transplantation