Randomized Study of Decitabine in Maintenance Therapy of Acute Myeloid Leukemia (AML)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Study of Decitabine Versus Observation or Continued Standard Chemotherapy as Maintenance Therapy for Adults With Unfavorable Risk AML in First Complete Remission (CR) or Adults With Relapsed AML in Second or Greater CR|
- Number of Participants With Relapse-Free Response at 1 Year [ Time Frame: Baseline to 1 year ] [ Designated as safety issue: No ]Relapse free response defined an absence of relapse at one year of follow up.
|Study Start Date:||August 2006|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: Decitabine 20 mg/m^2
20 mg/m^2 intravenous (IV) daily for 5 days
20 mg/m^2 IV over 1 hour daily for 5 days
Other Name: Dacogen
No Intervention: No Study Drug
Continue current therapy.
Methylation is a change that occurs to DNA that has an effect on how genes are used in human cells. It is very common in leukemias for methylation to happen abnormally. Decitabine is a new drug that blocks DNA methylation. At low doses (such as those used in this study), decitabine blocks proteins important in abnormal DNA methylation, which may, in turn, allow leukemia cells to die and disappear.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 groups. Group 1 will receive decitabine about every 4-8 weeks to see whether this drug is useful in lengthening the duration of remission in patients like you. Group 2 will not receive the study drug.
If you are assigned to Group 1, the drug will be given over about 1 hour through a peripheral or central catheter every day for 5 days. A peripheral or central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure. You will receive the study drug for 5 days per study "cycle". Each cycle will be about 4-8 weeks. You must receive your study drug at M. D. Anderson Cancer Center.
You may remain on study for up to 12 Cycles. You will be taken off study if the disease gets worse, your doctor feels it is in your best interest, or you develop intolerable side effects.
During the study, blood (about 2 tablespoons) will be drawn for routine tests every week during the first month and then every 2-4 weeks after that. You will also have a bone marrow examination aspirate/biopsy every 3-6 months to make sure that your disease remains in remission.
If you are assigned to Group 2, you will continue under the care of your doctor. This will include study visits and having a bone marrow examination aspirate/biopsy every 3-6 months up to one year after randomization to make sure that the disease remains in remission.
Once you are off study, blood (about 2 tablespoons) will be drawn and you will have a bone marrow biopsy/aspirate.
This is an investigational study. Decitabine is FDA-approved and is commercially available. It is not FDA approved for this usage, and it has been authorized for use in research only. Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398983
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Farhad Ravandi-Kashani, MD||M.D. Anderson Cancer Center|