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:

Completed

Phase:

Phase 2

Trial Eligibility

Document

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

  • ORG STUDY ID: 2012-0507
  • SECONDARY ID: NCI-2012-02215
  • NCT ID: NCT01720225

Conditions

  • Leukemia

Interventions

DrugSynonymsArms
DecitabineDAC, DacogenDecitabine
AzacitidineAZA, 5-azacytidine, 5-aza, Vidaza, 5-AZC, AZA-CR, Ladakamycin, NSC-102816Azacitidine

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

NameTypeDescriptionInterventions
DecitabineExperimentalPatients randomized to receive Decitabine 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.
  • Decitabine
AzacitidineExperimentalPatients 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 Institutional Review Board (IRB)-approved informed consent document.

          2. Age >/= than18 years

          3. de novo or secondary International Prostate Symptom Score (IPSS) low- or
             intermediate-1 - risk MDS, including CMML

          4. Eastern Cooperative Oncology Group (ECOG) performance status of </= 3 at study entry.

          5. Organ function as defined: Serum creatinine </= 3 x Upper Limit of Normal (ULN), Total
             bilirubin </= 2 x ULN, Alanine transaminase (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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Participants With a Response
Time Frame:56 days
Safety Issue:
Description:Overall Response = complete remission (CR) + partial remission (PR) + marrow CR (mCR) + hematologic improvement (HI). CR is normalization of peripheral blood and bone marrow with <5% bone marrow blasts, a peripheral blood granulocyte count > (1.0 x 10^9/L, and platelet count > 100 x 10^9/L). PR is same as CR except for the presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment. Marrow CR is blasts </= 5% and decreased by >/=50% from baseline. HI is platelets increase by 50% and to above 30 x 10^9/L untransfused (if lower than that pre-therapy; or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by > 50%; or monocytosis reduction by > 50% if pretreatment > 5 X1 0^9/L.

Secondary Outcome Measures

Measure:Number of Participants Who Became Transfusion Independent
Time Frame:8 weeks
Safety Issue:
Description:Participants who were transfusion dependent at baseline prior to starting therapy on the Decitabine or Azacitidine arm will be analyzed for transfusion independence. Transfusion independence defined as being transfusion-free for ≥8 consecutive weeks between the first dose and study treatment discontinuation.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:M.D. Anderson Cancer Center

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

Last Updated

December 24, 2020