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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01259 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Celgene | INDUSTRY |
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The goal of this clinical research study is to learn if Vidaza (azacitidine) will help to control the disease in patients with AML, CMML, or MDS after an allogeneic (donor) stem cell transplant. The safety of this drug will also be studied.
The Study Drug:
Azacitidine is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may be able to work better.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in a flip of a coin) to 1 of 2 groups.
Study Drug Administration:
If you are in Group 1, you will receive azacitidine through a needle under your skin on Days 1-5 of each cycle.
Each cycle is 28 days long.
Your dose of azacitidine may be lowered or stopped if certain side effects develop.
Study Visits:
About 2 or 3 days before each cycle and, if your doctor thinks it is needed, on Day 3 of each cycle and 1 time during Weeks 2 and 3 of each cycle, blood (about 4 teaspoons each time) will be drawn for routine tests.
At 3, 6, and 12 months after the stem cell transplant:
You may come back for study visits more often if the doctor thinks it is needed.
While on study, you will need to stay in Houston for about 3 months after the transplant (this is standard after stem cell transplants).
Length of Study:
You will be on study treatment for up to 1 year (up to 12 cycles of azacitidine). You will be taken off study early if you experience intolerable side effects or the disease gets worse.
End-of-Treatment Visit:
After you complete the planned treatment with azacitidine, you will have an end-of-treatment visit:
This is an investigational study. Azacitidine is FDA approved and is commercially available for the treatment of myelodysplastic syndrome.
Up to 246 patients will take part in this study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azacitidine | Experimental | Azacitidine 32 mg/m^2 given through a needle under the skin for five consecutive days of each 28 day cycle and the maximum treatment will be 12 cycles. |
|
| No Azacitidine | No Intervention | Standard treatment post allogeneic transplant is supportive care only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azacitidine | Drug | 32 mg/m^2 given through a needle under the skin for five consecutive days of each 28 day cycle and the maximum treatment will be 12 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free Survival (RFS) | The time that a participant survives without relapse of the disease. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | 3 years |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard E. Champlin, MD, BS | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33170934 | Derived | Oran B, de Lima M, Garcia-Manero G, Thall PF, Lin R, Popat U, Alousi AM, Hosing C, Giralt S, Rondon G, Woodworth G, Champlin RE. A phase 3 randomized study of 5-azacitidine maintenance vs observation after transplant in high-risk AML and MDS patients. Blood Adv. 2020 Nov 10;4(21):5580-5588. doi: 10.1182/bloodadvances.2020002544. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Patients were randomized to receive azacitidine (AZA) or standard of care 40 to 100 days after allo SCT.
Recruitment was from September 2009 to April 2017 for high risk subjects with acute myelogenous leukemia (AML) and myelodysplastic (MDS) patients who have undergone an allogeneic transplant.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZA Group | Subjects randomized to the AZA treatment will receive 32 mg/m2 for 5 consecutive days of each 28 day cycle and the maximum treatment will be 12 cycles. Each cycle will consist of approximately 28 days, allowing the possibility that treatment within a cycle may be delayed for up to 4 weeks due to organ toxicity or hematologic toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2015 |
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|
| FG001 |
| Standard of Care Group |
Best standard of care (ie, no maintenance) |
| COMPLETED |
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| NOT COMPLETED |
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Enrolled patients were randomly assigned; in a 1:1 ratio; to 12 cycles of azacitidine (at a dose of 32 mg per square meter of body surface area per day, administered by subcutaneous injections for 5 days every 4 weeks) or to observation (no further treatment). The randomization was stratified by disease (AML, MDS, biphenotypic leukemia).
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| ID | Title | Description |
|---|---|---|
| BG000 | AZA Group | Subjects randomized to the AZA treatment will receive 32 mg/m2 for 5 consecutive days of each 28 day cycle and the maximum treatment will be 12 cycles. Each cycle will consist of approximately 28 days, allowing the possibility that treatment within a cycle may be delayed for up to 4 weeks due to organ toxicity or hematologic toxicity. |
| BG001 | Standard of Care Group | Best standard of care (ie, no maintenance) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Disease Strata | The randomization was stratified by disease (AML, MDS, biphenotypic leukemia). | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Relapse-free Survival (RFS) | The time that a participant survives without relapse of the disease. | Posted | Median | Standard Deviation | years | 3 years |
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| Secondary | Overall Survival (OS) | Posted | Median | Standard Deviation | years | 3 years |
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From time of enrollment dependent on randomization would be one month from last day of study drug or one year if in standard of care group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZA Group | Subjects randomized to the AZA treatment will receive 32 mg/m2 for 5 consecutive days of each 28 day cycle and the maximum treatment will be 12 cycles. Each cycle will consist of approximately 28 days, allowing the possibility that treatment within a cycle may be delayed for up to 4 weeks due to organ toxicity or hematologic toxicity. | 0 | 87 | 0 | 87 | 29 | 87 |
| EG001 | Standard of Care Group | Best standard of care (ie, no maintenance) | 1 | 94 | 0 | 94 | 19 | 94 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Poor Graft function | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Gastrointestetinal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Hepatic | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
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| Pulmonary | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard E. Champlin, MD/ Chair, Stem Cell Transplantation | UT MD Anderson Cancer Center | 713-792-3618 | rchampli@mdanderson.org |
| Dec 19, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| MDS |
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| Biphenotypic Leukemia |
|
|