Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398983
Status:
COMPLETED
Last Update Posted:
2013-03-04
First Post:
2006-11-09
Brief Title:
Randomized Study of Decitabine in Maintenance Therapy of Acute Myeloid Leukemia AML
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical study is to find out whether continued therapy with decitabine after achieving a remission in acute myeloid leukemia AML patients can help prolong the remission and prevent relapse of the disease
Detailed Description:
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 aspiratebiopsy 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 aspiratebiopsy 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 biopsyaspirate
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
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 aspiratebiopsy 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 aspiratebiopsy 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 biopsyaspirate
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None