Status:
COMPLETED
Azacitidine Maintenance Therapy After Allogeneic Bone Marrow Transplantation (Allo BMT)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Celgene Corporation
Conditions:
Myelodysplastic Syndrome
Leukemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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:...
Detailed Description
Azacitidine is a drug that is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00350818
Start Date
October 1 2005
End Date
August 1 2010
Last Update
July 30 2012
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030