Decitabine Versus Azacitidine in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk
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ClinicalTrials.gov Identifier: NCT01720225 |
Recruitment Status :
Completed
First Posted : November 2, 2012
Results First Posted : December 24, 2020
Last Update Posted : December 24, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | October 31, 2012 | ||||
First Posted Date ICMJE | November 2, 2012 | ||||
Results First Submitted Date ICMJE | December 1, 2020 | ||||
Results First Posted Date ICMJE | December 24, 2020 | ||||
Last Update Posted Date | December 24, 2020 | ||||
Actual Study Start Date ICMJE | November 6, 2012 | ||||
Actual Primary Completion Date | January 8, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Participants With a Response [ Time Frame: 56 days ] 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.
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Original Primary Outcome Measures ICMJE |
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 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.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
Number of Participants Who Became Transfusion Independent [ Time Frame: 8 weeks ] 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.
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Original Secondary Outcome Measures ICMJE |
Transfusion Independence [ Time Frame: 8 weeks ] Transfusion independence defined as being transfusion-free for ≥8 consecutive weeks between the first dose and study treatment discontinuation.
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Decitabine Versus Azacitidine in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | 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. |
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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:
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Leukemia | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Jabbour E, Short NJ, Montalban-Bravo G, Huang X, Bueso-Ramos C, Qiao W, Yang H, Zhao C, Kadia T, Borthakur G, Pemmaraju N, Sasaki K, Estrov Z, Cortes J, Ravandi F, Alvarado Y, Komrokji R, Sekeres MA, Steensma DP, DeZern A, Roboz G, Kantarjian H, Garcia-Manero G. Randomized phase 2 study of low-dose decitabine vs low-dose azacitidine in lower-risk MDS and MDS/MPN. Blood. 2017 Sep 28;130(13):1514-1522. doi: 10.1182/blood-2017-06-788497. Epub 2017 Aug 3. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
113 | ||||
Original Estimated Enrollment ICMJE |
120 | ||||
Actual Study Completion Date ICMJE | January 8, 2020 | ||||
Actual Primary Completion Date | January 8, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01720225 | ||||
Other Study ID Numbers ICMJE | 2012-0507 NCI-2012-02215 ( Registry Identifier: NCI CTRP ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | M.D. Anderson Cancer Center | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | ||||
Verification Date | December 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |