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Phase II Randomized Study of Lower Doses of Decitabine (DAC; 20 mg/m2 IV Daily for 3 Days Every Month) Versus Azacitidine (AZA; 75 mg/m2 SC/IV Daily for 3 Days Every Month) in Myelodysplastic Syndrome (MDS) Patients With Low and Intermediate-1 Risk Disease


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

Phase II Randomized Study of Lower Doses of Decitabine (DAC; 20 mg/m2 IV Daily for 3 Days Every Month) Versus Azacitidine (AZA; 75 mg/m2 SC/IV Daily for 3 Days Every Month) in Myelodysplastic Syndrome (MDS) Patients With Low and Intermediate-1 Risk Disease


Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to 1 of 2 groups:

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

- If you are in Group 2, you will receive azacitidine either as an injection under your
skin or through a vein. If by vein, the infusion will take about an hour.

At first, there will be an equal chance of being assigned to either group. However, as the
study goes on and more information becomes available, the chance of being assigned to the
group that has shown the most effectiveness will increase. However, once you are already
enrolled and assigned to a group, you will not be eligible to change groups.

Study Drug Administration:

Each cycle is 28 days.

You will receive the study drug on Days 1-3 of every cycle and you will receive at least 2
cycles of study drug.

Study Visits:

Every 7-14 days, blood (about 2 tablespoons) will be drawn for routine tests.

Every 2-4 cycles until any point that the disease appears to have responded to the study
drug, then as often as the study doctor thinks is necessary, you will have a bone marrow
biopsy and/or aspirate to check the status of the disease. To collect a bone marrow
biopsy/aspirate, an area of the hip bone is numbed with anesthetic, and a small amount of
bone and/or bone marrow is withdrawn through a large needle.

The frequency of the visits will depend on what the doctor thinks is in your best interest.

Length of Study:

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.

Follow-Up Visits:

One (1) time every 3 months after your last dose of study drug, you will return to the
clinic for a bone marrow aspiration to check the status of the disease.

This is an investigational study. Decitabine and Azacitidine are both FDA approved and
commercially available for use in patients with MDS.

Up to 120 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Sign an IRB-approved informed consent document.

2. Age >/= than 18 years

3. de novo or secondary IPSS low- or intermediate-1 - risk MDS, including CMML

4. ECOG performance status of
5. Organ function as defined: Serum creatinine ALT (SGPT)
6. Women of childbearing potential must have a negative serum or urine pregnancy test
within 7 days and will also need to use contraceptives. Men must agree not to father
a child and agree to use a condom if his partner is of child bearing potential.

Exclusion Criteria:

1. Breast feeding females

2. Prior therapy with decitabine or azacitidine

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Improvement Rate (OIR)

Outcome Description:

Overall improvement rate (OIR), defined as complete remission (CR), partial remission (PR), marrow CR (mCR), or hematologic improvement (HI), measured at the end of each cycle using each patient's best response with the 2 different agents. Response assessed using the modified International Working Group 2006 criteria. The best response within the first two cycles will be the OIR for each treatment arm that will be used in the adaptive randomization algorithm.

Outcome Time Frame:

56 days

Safety Issue:

Yes

Principal Investigator

Elias Jabbour, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2012-0507

NCT ID:

NCT01720225

Start Date:

November 2012

Completion Date:

Related Keywords:

  • Leukemia
  • Leukemia
  • Myelodysplastic syndromes
  • MDS
  • Low and Intermediate-1 Risk Disease
  • Decitabine
  • DAC
  • Dacogen
  • Azacitidine
  • AZA
  • 5-azacytidine
  • 5-aza
  • Vidaza
  • 5-AZC
  • AZA-CR
  • Ladakamycin
  • NSC-102816
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030