Controlled Study of Post-transplant Azacitidine for Prevention of Acute Myelogenous Leukemia and Myelodysplastic Syndrome Relapse (VZ-AML-PI-0129)
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|ClinicalTrials.gov Identifier: NCT00887068|
Recruitment Status : Completed
First Posted : April 23, 2009
Results First Posted : January 14, 2020
Last Update Posted : January 14, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Leukemia AML MDS||Drug: Azacitidine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||187 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Study of Post-transplant Azacitidine for Prevention of Acute Myelogenous Leukemia and Myelodysplastic Syndrome Relapse (VZ-AML-PI-0129)|
|Actual Study Start Date :||April 21, 2009|
|Actual Primary Completion Date :||August 20, 2018|
|Actual Study Completion Date :||August 20, 2018|
Azacitidine 32 mg/m^2 given through a needle under the skin for five consecutive days of each 28 day cycle and the maximum treatment will be 12 cycles.
32 mg/m^2 given through a needle under the skin for five consecutive days of each 28 day cycle and the maximum treatment will be 12 cycles.
No Intervention: No Azacitidine
Standard treatment post allogeneic transplant is supportive care only.
- Relapse-free Survival (RFS) [ Time Frame: 3 years ]The time that a participant survives without relapse of the disease.
- Overall Survival (OS) [ Time Frame: 3 years ]
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00887068
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Richard E. Champlin, MD, BS||M.D. Anderson Cancer Center|
Documents provided by M.D. Anderson Cancer Center:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||M.D. Anderson Cancer Center|
|Other Study ID Numbers:||
NCI-2012-01259 ( Registry Identifier: NCI CTRP )
|First Posted:||April 23, 2009 Key Record Dates|
|Results First Posted:||January 14, 2020|
|Last Update Posted:||January 14, 2020|
|Last Verified:||January 2020|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Acute myelogenous leukemia
Allogeneic stem cell transplant
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Bone Marrow Diseases
Molecular Mechanisms of Pharmacological Action