Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
34 participants
INTERVENTIONAL
2005-06-30
2008-04-30
Brief Summary
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Detailed Description
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If you are found to be eligible to take part in this study, you will be able to begin treatment with azacitidine. You will receive azacitidine as an injection under the skin once a day for 7 days in a row. This will be repeated every 4 weeks (4 weeks equals 1 cycle). The first cycle of azacitidine will be given at M. D. Anderson, in an outpatient setting. Later cycles of treatment courses may be given at M. D. Anderson or by a cancer doctor in your community.
You may receive up to 12 cycles of treatment if you are responding well to treatment. You will be taken off study if your disease gets worse or intolerable side effects occur. Once you go off study, you will receive follow-up as is standard of care for your disease.
This is an investigational study. Azacitidine is FDA approved for the treatment of myelodysplastic syndrome. Its use in this study is experimental. A total of up to 34 patients will take part in this study. All will be enrolled at M. D. Anderson.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Azacitidine
75 mg/m\^2 Subcutaneous Daily for 7 days every 4 weeks
Azacitidine
75 mg/m\^2 subcutaneous daily for 7 days (every 4 week cycle)
Interventions
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Azacitidine
75 mg/m\^2 subcutaneous daily for 7 days (every 4 week cycle)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Performance 0-2 Eastern Cooperative Oncology Group (ECOG).
* Signed informed consent.
* Patients must have been off chemotherapy for 2 weeks prior to entering this study and have recovered from the toxic effects (grade 0-1) of that therapy. Patients are allowed to be on anagrelide and hydroxyurea to control high platelet and WBC counts for their safety.
* Serum bilirubin levels \</= 1.5 times the upper limit of the normal range for the laboratory Upper Limit of of Normal(ULN). Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.
* Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) levels \</= 2 x ULN.
* Serum creatinine levels \</= 1.5 x ULN; unless related to the MF, as judged by treating physicians.
* Women of childbearing potential must have a negative serum pregnancy test prior to azacitidine treatment and should be advised to avoid becoming pregnant. Men must be advised to not father a child while receiving treatment with azacitidine. Both women of childbearing potential and men must practice effective methods of contraception (those generally accepted as standard of care measures).
* Age \>/= 18.
Exclusion Criteria
* Uncontrolled intercurrent illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
* Known or suspected hypersensitivity to azacitidine or mannitol.
18 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Srdan Verstovsek, M.D.
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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M.D. Anderson's Website
Other Identifiers
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2005-0033
Identifier Type: -
Identifier Source: org_study_id