Status:
COMPLETED
Controlled Study of Post-transplant Azacitidine for Prevention of Acute Myelogenous Leukemia and Myelodysplastic Syndrome Relapse (VZ-AML-PI-0129)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Celgene
Conditions:
Leukemia
AML
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The goal of this clinical research study is to learn if Vidaza (azacitidine) will help to control the disease in patients with AML, CMML, or MDS after an allogeneic (donor) stem cell transplant. The s...
Detailed Description
The Study Drug: Azacitidine 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...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of AML (World Health Organization classification: \>=20% blasts in the bone marrow and / or peripheral blood) or MDS (International Prognostic Scoring System intermediate-1 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 1 cycle of treatment to achieve the remission, or that have AML evolving from MDS, or that had the following abnormalities: FLT3 mutation, deletion of chromosome 5 or 7, MLL gene rearrangement, or more than or equal to 3 cytogenetics abnormalities. Patients with de novo or therapy-related MDS, CMML, or AML are also eligible, regardless of cytogenetics or molecular rearrangements.
- Biphenotypic Leukemia that at the time of allogeneic transplantation was in induction failure, relapsed disease, first, second or greater remission.
- Patients must be in complete remission post transplant.
- Patient may be enrolled 40 to 100 days after transplant.
- Age 18 to 75 years old.
- Serum creatinine \< 1.8 mg/dL or creatinine clearance greater or equal than 40 cc/min as defined by the Cockcroft-Gault Equation\*. a. Males(mL/min):(140-age)\*IBW(kg) / 72\*(serum creatinine(mg/dl)) b. Females(mL/min):0.85\*(140-age)\*IBW(kg) / 72\*(serum creatinine(mg/dl)).
- Serum direct bilirubin \< 1.5 mg/dL (unless Gilbert's syndrome).
- SGPT \</= 200 IU/ml unless related to patient's malignancy.
- Be able to understand and sign informed consent.
Exclusion
- Active uncontrolled infection.
- Presence of uncontrolled graft-versus-host disease.
- Patients that underwent allogeneic transplantation as a treatment of graft failure.
- Pregnancy or breast-feeding (women of childbearing potential, any female who has experienced menarche and who has not undergone surgical sterilization or is not post-menopausal with a positive serum pregnancy test.
- Known or suspected hypersensitivity to azacitidine or mannitol.
- Patients with advanced malignant hepatic tumors.
Key Trial Info
Start Date :
April 21 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2018
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT00887068
Start Date
April 21 2009
End Date
August 20 2018
Last Update
January 14 2020
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030