Randomized Study of Decitabine in Maintenance Therapy of Acute Myeloid Leukemia (AML) - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Eisai Inc.
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00398983

Purpose

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.

Condition	Intervention	Phase
Acute Myelogenous Leukemia	Drug: Decitabine	Phase II Phase III

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Acute Myeloid Leukemia Cancer Leukemia

Drug Information available for: 5-Aza-2'-deoxycytidine

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Number of Patients with Relapse-Free Response [ Time Frame: Baseline to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	August 2006
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Decitabine 20 mg/m^2 20 mg/m^2 daily x 5	Drug: Decitabine 20 mg/m^2 IV over 1 hour daily x 5 days Other Name: Dacogen
No Intervention: No Study Drug Continue current therapy.

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.

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded. You will have a physical exam. Blood (about 2 tablespoons) will be drawn for routine tests. You will have a bone marrow aspiration/biopsy to confirm that you are in remission. To collect a bone marrow aspirate/biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow/bone is withdrawn through a large needle. Women who are able to have children must have a negative blood (about 1/2 tablespoon) or urine pregnancy test.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients (greater than 18 years) with AML by WHO criteria (greater than 20% blasts) and unfavorable risk cytogenetics (including intermediate and poor risk categories) in first CR or CRp (complete remission without full platelet recovery)
Adult patients (greater than 18 years) in second or subsequent CR (or CRp)
Patients in first CR (or CRp) may have received any induction chemotherapy regimen; they may have received post-remission consolidation therapy (except for transplant) prior to inclusion in this protocol
Patients in 2nd or subsequent CR (or CRp) may have received any appropriate salvage regimen before achieving CR and may have received further therapy before inclusion
Performance status of 0, 1, or 2
Adequate organ function with creatinine less than or equal to 2.0 mg/dL, bilirubin less than or equal to 3.5 mg/dL and ALT and AST less than or equal to 3 times institutional upper limit of normal

Exclusion Criteria:

Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization
Known to be HIV+
Active and uncontrolled disease/infection as judged by the treating physician
Unable or unwilling to sign the consent form
No other investigational therapy within the past 14 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398983

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Eisai Inc.

Investigators

Principal Investigator:

Farhad Ravandi-Kashani, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Anderson's website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00398983 History of Changes
Other Study ID Numbers:	2006-0358
Study First Received:	November 9, 2006
Last Updated:	October 20, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Acute Myelogenous Leukemia
AML
Remission
Decitabine
Maintenance Therapy

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Decitabine
Antimetabolites, Antineoplastic

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012