Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia (AML) in CR After Induction Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00387647|
Recruitment Status : Completed
First Posted : October 13, 2006
Results First Posted : June 30, 2014
Last Update Posted : August 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Azacitidine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Phase 2 Study of Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia in Complete Remission After Induction Chemotherapy|
|Study Start Date :||August 2006|
|Primary Completion Date :||October 2013|
|Study Completion Date :||August 2014|
Experimental: Azacitidine Treatment
Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles.
Azacitidine given subcutaneously as outlined in treatment arm.
Other Name: Vidaza™
- Rate of Disease Free Survival at One Year [ Time Frame: 1 year ]The primary efficacy variable is disease free survival measured at one year, which is the percentage of patients who remain alive and disease free one year after the confirmation of remission by bone marrow biopsy. Relapse is defined by a bone marrow specimen with >5% blasts or the presence of Auer rods.
- Overall Survival (OS) [ Time Frame: 48 months ]The secondary efficacy variable is overall survival measured as time to death, which is the time from remission until death from any cause.
- Number of Participants With Adverse Events [ Time Frame: 48 months ]Safety and tolerability of treatment as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0
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): NCT00387647
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Jeffrey E. Lancet, M.D.||H. Lee Moffitt Cancer Center and Research Institute|