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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


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Acute Myelogenous Leukemia

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Trial Information

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


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.


Inclusion Criteria:



- Adult patients (greater than 18 years) with acute myelogenous leukemia (AML) by World
Health Organization (WHO) criteria (greater than 20% blasts) and unfavorable risk
cytogenetics (including intermediate and poor risk categories) in first CR or
complete remission without full platelet recovery (CRp)

- Adult patients (greater than 18 years) in second or subsequent Complete Response (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 aspartate aminotransferase (AST or SGOT) and
alanine aminotransferase (ALT or SGPT) 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Relapse-Free Response at 1 Year

Outcome Description:

Relapse free response defined an absence of relapse at one year of follow up.

Outcome Time Frame:

Baseline to 1 year

Safety Issue:

No

Principal Investigator

Farhad Ravandi-Kashani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2006-0358

NCT ID:

NCT00398983

Start Date:

August 2006

Completion Date:

May 2012

Related Keywords:

  • Acute Myelogenous Leukemia
  • Acute Myelogenous Leukemia
  • AML
  • Remission
  • Decitabine
  • Maintenance Therapy
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030