Azacitidine Maintenance Therapy After Allogeneic Bone Marrow Transplantation (Allo BMT)

Completed · Phase 1

Conditions studied: Myelodysplastic Syndrome, Leukemia

In brief

Primary Objective: -To determine the dose and schedule combination of 5-Azacitidine, when used as maintenance treatment after allogeneic transplantation for high-risk AML / MDS. Secondary Objective: -To assess the effect of treatment on survival after allogeneic transplantation for high-risk AML / MDS.

Key facts

Study ID

NCT00350818

Run by

M.D. Anderson Cancer Center

People needed

90

Starts

2005-10-01

Expected to finish

2010-08-01

Last updated by the study team

2012-07-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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