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

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia

Intervention: Azacitidine (AZA) Days 1 - 3 (Drug); Decitabine (DAC) (Drug); Best Supportive Care (BSC) (Other); Azacitidine (AZA) Days 1 - 5 (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Elias Jabbour, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

Overall contact:
Elias Jabbour, MD, Phone: 713-792-4764

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.

Clinical Details

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

Primary outcome: Event Free Survival (EFS)

Secondary outcome: Overall improvement rate (OIR)

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. 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 40 will take part at MD Anderson.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Sign an IRB-approved informed consent document. 2. Age >/= 18 years. 3. de novo or secondary IPSS low- or intermediate-1-risk MDS, including CMML-1 4. ECOG performance status of

Locations and Contacts

Elias Jabbour, MD, Phone: 713-792-4764

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612, United States; Recruiting

Johns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland 21287, United States; Recruiting

Dana-Farber Cancer Institute, Boston, Massachusetts 02215, United States; Recruiting

Weill Medical College of Cornell University, New York, New York 10065, United States; Recruiting

The Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States; Recruiting

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting

Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: October 2014
Last updated: May 27, 2015

Page last updated: August 23, 2015

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