Status:
COMPLETED
A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care
Lead Sponsor:
Celgene
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether patients with high-risk myelodysplastic syndromes (MDS) treated with azacitidine have improved survival compared to conventional care treatments. The ...
Detailed Description
Comparison/Control Interventions offered the physician three options: * Best supportive care (BSC) alone, * Low-dose cytarabine subcutaneously for 14 days every 28 to 42 days, or * Standard chemother...
Eligibility Criteria
Inclusion
- Have a diagnosis of refractory anemia with excess blasts or refractory anemia with excess blasts in transformation according to the French-American-British classification system for myelodysplastic syndromes (MDS) and a relatively high risk of acute myeloid leukemia (AML) transformation, with an International Prognostic Scoring System score of INT-2 or High.
- Be 18 years of age or older
- Have a life expectancy of at least 3 months
- Be unlikely to proceed to bone marrow or stem cell transplantation therapy following remission
- Have serum bilirubin levels less than or equal to 1.5 times the upper limit of normal range for the laboratory
- Have serum glutamic-oxaloacetic transaminase (aspartate aminotransferase) or serum glutamic-pyruvic transaminase (alanine aminotransferase) levels less than or equal to 2 times the upper limit of normal (unless these are considered to be related to transfusion-induced secondary hemosiderosis)
- Have serum creatinine levels less than or equal to 1.5 times the upper limit of normal
Exclusion
- Secondary myelodysplastic syndromes (MDS)
- Prior treatment with azacitidine;
- Prior history of acute myeloid leukemia (AML);
- Malignant disease diagnosed within prior 12 months;
- Metastatic disease;
- Hepatic tumors;
- Radiation, chemotherapy, cytotoxic therapy for non-MDS conditions within prior 12 months;
- Prior transplantation or cytotoxic therapy to treat MDS;
- Serious medical illness likely to limit survival to 12 months or less;
- Treatment with erythropoietin or myeloid growth factors during prior 21 days or androgenic hormones during prior 13 days;
- Active HIV, viral hepatitis type B or C;
- Treatment with investigational drugs during prior 30 days;
- Within the 28-day screening period, documented red cell folate deficiency, as evidenced by red blood cell folate (not serum folate) or vitamin B12 deficiency
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
358 Patients enrolled
Trial Details
Trial ID
NCT00071799
Start Date
November 1 2003
End Date
July 1 2007
Last Update
October 29 2019
Active Locations (108)
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1
University of Alabama School of Medicine
Birmingham, Alabama, United States, 35294
2
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110
4
Mount Sinai Medical Center
New York, New York, United States, 10029-6574