Clinical Trials /

Decitabine Versus Azacitidine in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk

NCT01720225

Description:

The goal of this clinical research study is to compare how two different drugs, decitabine and azacitidine, when given on a shorter than standard dosing schedule can help to control MDS. The safety of the drugs will also be studied. Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die. Azacitidine is designed to block certain proteins in cancer cells whose job is to stop the function of the tumor-fighting proteins. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better. This could cause the cancer cells to die.

Related Conditions:
  • Myelodysplastic Syndromes
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Decitabine Versus <span class="go-doc-concept go-doc-intervention">Azacitidine</span> in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk

Title

  • Brief Title: Decitabine Versus Azacitidine in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk
  • Official Title: 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
  • Clinical Trial IDs

    NCT ID: NCT01720225

    ORG ID: 2012-0507

    NCI ID: NCI-2012-02215

    Trial Conditions

    Leukemia

    Trial Interventions

    Drug Synonyms Arms
    Decitabine DAC, Dacogen Decitabine
    Azacitidine AZA, 5-azacytidine, 5-aza, Vidaza, 5-AZC, AZA-CR, Ladakamycin, NSC-102816 Azacitidine

    Trial Purpose

    The goal of this clinical research study is to compare how two different drugs, decitabine
    and azacitidine, when given on a shorter than standard dosing schedule can help to control
    MDS. The safety of the drugs will also be studied.

    Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause
    cancer cells to die.

    Azacitidine is designed to block certain proteins in cancer cells whose job is to stop the
    function of the tumor-fighting proteins. By blocking the "bad" proteins, the tumor-fighting
    genes may be able to work better. This could cause the cancer cells to die.

    Detailed Description

    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.

    At the end of Cycle 2, you will have a bone marrow biopsy and/or aspirate to check the
    status of the disease. This will then be repeated 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. 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.

    After Cycle 3:

    If the study doctor decides it is acceptable, you may be allowed to receive treatment from
    your local cancer doctor. However, you have to return to Houston at least every 3 months for
    your study visits.

    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.

    Other Information:

    You may be given other drugs to help prevent side effects. The study staff will tell you
    about these drugs, how they will be given, and the possible risks.

    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.

    Trial Arms

    Name Type Description Interventions
    Decitabine Experimental Patients randomized to receive Decitabine 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days. Decitabine
    Azacitidine Experimental Patients randomized to receive Azacitidine 75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days. Azacitidine

    Eligibility Criteria

    Inclusion Criteria:

    1. Sign an IRB-approved informed consent document.

    2. Age >/= than18 years

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

    4. ECOG performance status of </= 3 at study entry.

    5. Organ function as defined: Serum creatinine </= 3 x ULN, Total bilirubin </= 2 x ULN,
    ALT (SGPT) </= 2 x ULN

    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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Overall Improvement Rate (OIR)

    Secondary Outcome Measures

    Transfusion Independence

    Trial Keywords

    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