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Phase II Decitabine (DAC) Versus Azacitidine (AZA) in Myelodysplastic Syndrome (MDS)

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ClinicalTrials.gov Identifier: NCT02269280
Recruitment Status : Recruiting
First Posted : October 21, 2014
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
MDS Consortium
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to compare how 2 different drugs, decitabine and azacitidine, when given on a shorter than standard dosing schedule, may help to control MDS. The safety of each study drug given on these schedules will also be studied.

This is an investigational study. Decitabine and azacitidine are both FDA approved and commercially available for use in patients with MDS. Giving these drugs on a different schedule than is standard is considered investigational.

The study doctor can tell you how the study drugs are designed to work.

Up to 240 participants will be enrolled in this multicenter study. Up to 157 will take part at MD Anderson.


Condition or disease Intervention/treatment Phase
Leukemia Drug: Azacitidine (AZA) Days 1 - 3 Drug: Decitabine (DAC) Other: Best Supportive Care (BSC) Drug: Azacitidine (AZA) Days 1 - 5 Phase 2

Detailed Description:

Study Groups and Study Drug Administration:

Each cycle is approximately 28 days.

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 4 groups:

  • If you are in Group 1, you will receive decitabine by vein over about 1 hour on Days 1-3 of every cycle.
  • If you are in Group 2, you will receive azacitidine either as an injection under your skin or by vein on Days 1-3 of every cycle.
  • If you are in Group 3, you will receive azacitidine either as an injection under your skin or by vein on Days 1-5 of every cycle.
  • If you are in Group 4, you will receive the standard of care. The study doctor can explain the treatment you will receive and the risks involved.

Transfusion-dependent participants will be randomly assigned to 1 of 3 groups

This is done because no one knows if one study group is better, the same, or worse than the other group. If you are among the first 20 participants, you will have an equal chance of being in any of the groups. If you enroll after that, you will have a higher chance of being assigned to the group that has had better results.

However, once you are assigned to a group, you will not be allowed to change groups.

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.

Study Visits:

One (1) time each month, blood (about 2 tablespoons) will be drawn for routine tests.

At the end of Cycle 2, then every 3 cycles for the first year, then every 6 cycles, you will have a bone marrow biopsy and/or aspirate to check the status of the disease and for cytogenetic testing.

After Cycle 1, if the study doctor decides it is acceptable, you may be allowed to receive treatment from your local cancer doctor. However, you must return to Houston at least every 3 cycles for study visits. How often these visits will occur will depend on what the doctor thinks is in your best interest.

Length of Study:

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

Follow-Up:

When you are off-treatment, every 6 -12 months for up to 5 years, you will be called by a member of the study staff. You will be asked about any side effects you may be having. The phone calls will take about 5-10 minutes.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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) Versus Azacitidine (AZA; 75 mg/m2 SC/IV Daily for 5 Days Every Month) in MDS Patients With Low and Intermediate-1 Risk Disease Transfusion-Dependent Versus Best Supportive Care (BSC) in MDS Patients With Low and Intermediate-1 Risk Disease Transfusion-Independent
Study Start Date : October 2014
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Azacitidine (AZA) - Days 1 - 3
Azacitidine (AZA) Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
Drug: Azacitidine (AZA) Days 1 - 3
Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
Other Names:
  • 5-Azacytidine
  • 5-AZA
  • Vidaza
  • 5-AZC
  • AZA-CR
  • Ladakamycin
  • NSC-102816
  • Azacytidine

Experimental: Azacitidine (AZA) - Days 1 - 5
Azacitidine (AZA) 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
Drug: Azacitidine (AZA) Days 1 - 5
Azacitidine 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
Other Names:
  • 5-Azacytidine
  • 5-AZA
  • Vidaza
  • 5-AZC
  • AZA-CR
  • Ladakamycin
  • NSC-102816
  • Azacytidine

Experimental: Decitabine (DAC)
Decitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.
Drug: Decitabine (DAC)
Decitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.
Other Name: Dacogen

Best Supportive Care (BSC)
Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.
Other: Best Supportive Care (BSC)
Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.




Primary Outcome Measures :
  1. Event Free Survival (EFS) [ Time Frame: 56 days ]

    Event free survival (EFS) defined as the time from beginning of treatment till an event occurs or last follow-up. For transfusion independent patients, the events includes lack of response, requirement of blood transfusion, progression to advanced stages of disease, transformation into AML, discontinuation of therapy due to side effects, and death.

    For transfusion dependent patients, the events includes lack of response, progression to advanced stages of disease, transformation into AML, discontinuation of therapy due to side effects, and death.



Secondary Outcome Measures :
  1. Overall improvement rate (OIR) [ Time Frame: 56 days ]
    Overall improvement rate (OIR), defined as complete remission (CR), partial remission (PR), marrow CR (mCR), or hematologic improvement (HI), measured using each patient's best response with the 2 different agents. Response assessed using the modified MDS 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Sign an IRB-approved informed consent document.
  2. Age >/= 18 years.
  3. IPSS low- or intermediate-1-risk MDS, including CMML-1
  4. ECOG performance status of </= 3 at study entry.
  5. Organ function defined as: Serum creatinine </= 2 mg/dL; Total bilirubin </= 2 x ULN; ALT (SGPT) </= 2 x ULN; AST (SGOT) </= 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269280


Contacts
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Contact: Guillermo Garcia-Manero, MD 713-745-3428 ggarciam@mdanderson.org

Locations
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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
United States, Maryland
Johns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, New York
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10065
United States, Ohio
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
MDS Consortium
Investigators
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Principal Investigator: Guillermo Garcia-Manero, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02269280     History of Changes
Other Study ID Numbers: 2014-0112
NCI-2014-02339 ( Registry Identifier: NCI CTRP )
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Leukemia
Myelodysplastic syndrome
MDS
Low or intermediate-1 risk
Transfusion-dependent
Transfusion-independent
Best supportive care
BSC
Azacitidine
5-Azacytidine
5-AZA
Vidaza
5-AZC
AZA-CR
Ladakamycin
NSC-102816
Azacytidine
Decitabine
Dacogen

Additional relevant MeSH terms:
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Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Azacitidine
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors