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A Randomized Phase II Study of Two Schedules of Decitabine for Frontline Therapy of Older or Unfit Patients With Acute Myeloid Leukemia (AML)

Phase 2
60 Years
Open (Enrolling)

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Trial Information

A Randomized Phase II Study of Two Schedules of Decitabine for Frontline Therapy of Older or Unfit Patients With Acute Myeloid Leukemia (AML)

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to 1 of 2
dose levels of decitabine based on when you join this study. If you are among the first 20
participants, you will have an equal chance of being in either group. If you enroll after
that, you will have an increasingly higher chance (51-100%) of being assigned to the group
that had better results, depending on how much better that treatment arm is.

Study Drug Administration:

Each cycle is about 4-8 weeks, depending on the doctor's decision. In this study you will
receive induction therapy to try to control the disease and cause remission (this is when
tests and/or the doctor cannot find signs of the disease).

If you are in Group 1, you will receive decitabine by vein over about 1 hour for 5 days.

If you are in Group 2, you will receive decitabine by vein over about 1 hour for 10 days.

If the disease is in remission, you may receive more cycles (called maintenance) to help
keep the disease under control. If you are in Group 2, you will receive 5 day dosing during
maintenance, or when the doctor thinks it is in your best interest.

Your dose schedule or dose level may be changed if the doctor feels it is in your best

Study Visits:

The following tests and procedures will be performed:

- Blood (about 2-3 teaspoons) will be drawn 1-2 times weekly for first cycle, then every
2-4 weeks after that. After the 6th cycle or sooner if the doctor decides, this blood
draw will be performed only 1 time per cycle.

- Every 1-3 cycles, you will have a bone marrow aspiration/biopsy to check the status of
the disease. Blood (about 2-3 teaspoons) may also be drawn for genetic testing if the
disease is in remission and the doctor thinks it is needed.

Length of Treatment:

You may continue taking the study drug for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drug if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.

Your participation in this study will be over after the follow-up phone calls.


After you stop the study treatment, you will be called by phone twice a year and asked how
you are feeling. The phone calls should last about 5 minutes each time.

This is an investigational study. Decitabine is FDA approved and commercially available for
the treatment of myelodysplastic syndrome (MDS). Its use to treat AML is investigational.

Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria:

1. Patients with previously untreated AML (by the WHO criteria, i.e. >/= 20% blasts)
Prior biologic therapies (such as growth factors) and targeted therapies administered
for the treatment of prior myelodysplastic syndrome are allowed, with the exception
of hypomethylating agents 5-azacytidine or decitabine. Patients must have been off
such therapy for 1 week prior to entering this study and recovered from the toxic
effects of that therapy, unless there is evidence of rapidly progressive disease.
Hydroxyurea, and a single dose of cytarabine up to 3 g/m2, is permitted for control
of counts prior to treatment.

2. Patients >/= 60 are eligible if not a candidate for standard cytarabine plus
anthracycline chemotherapy as determined by Kantarjian's score (Appendix D) Patients
younger than 60 may also be included if felt not to be a candidate for intensive
anthracycline plus cytarabine based chemotherapy.

3. Performance 0-3 (ECOG).

4. Adequate liver function (Total bilirubin of < 2 mg/dl) unless due to hemolysis,
leukemia organ infiltration or Gilbert's syndrome and renal function (creatinine <
2.5 mg/dl).

5. Signed informed consent

Exclusion Criteria:

1. Nursing and pregnant females. Female patients of childbearing potential and male
patients should practice effective methods of contraception such as double barrier
method. Should a woman become pregnant or suspect she is pregnant while participating
in this study, she should inform her treating physician immediately. Negative urine
pregnancy test (women of childbearing potential)

2. Active and uncontrolled infections.

3. Uncontrolled intercurrent illness including, but not limited to, symptomatic
congestive heart failure, unstable angina pectoris, active significant other cancers
requiring chemotherapy and/or radiation therapy within past 6 months (excluding
non-melanoma skin cancer) or psychiatric illness/social situations that would limit
compliance with study requirements.

Type of Study:


Study Design:

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

Outcome Measure:

Response Rate

Outcome Description:

Primary efficacy outcome is complete response which is defined as the complete remission (CR) or complete remission with incomplete recovery (CRi) assessed after three cycles.

Outcome Time Frame:

up to 4 weeks cycles

Safety Issue:


Principal Investigator

Farhad Ravandi-Kashani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2013

Completion Date:

Related Keywords:

  • Leukemia
  • Leukemia
  • Acute myeloid leukemia
  • AML
  • Response rates
  • Decitabine
  • Dacogen
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



UT MD Anderson Cancer Center Houston, Texas  77030