Status:
COMPLETED
Alternative Dosing Regimens of Subcutaneous Azacitidine for Myelodysplastic Syndromes
Lead Sponsor:
Celgene
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if azacitidine, combined with Best Supportive Care (BSC), is effective in treating myelodysplastic syndromes (MDS) when given according to a different doses a...
Detailed Description
Comparison/Control Interventions: The comparison is azacitidine at different doses and schedules. Duration of Intervention: Treatment lasted for a maximum of 18 cycles, which is up to 24 months.
Eligibility Criteria
Inclusion
- Diagnosis of refractory anemia, refractory anemia with ringed sideroblasts and at least one of the following: a)Anemia with hemoglobin \<110g/L and requires at least 1 unit packed red blood cell transfusions every 28 days; b)Thrombocytopenia with platelet counts \<100 x 10\^9/L; or c)Neutropenia with absolute neutrophil count \<1.5 x 10\^9/L.
- OR, Refractory anemia with excess blasts or refractory anemia with excess blast in transformation, according to the French-American-British classification system for MDS.
- At least 18 years of age.
- Have a life expectancy of \>7 months.
- 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 the normal (ULN) 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 x ULN.
- Have serum creatinine levels less than or equal to 1.5 x ULN.
Exclusion
- Secondary MDS.
- Prior treatment with azacitidine.
- Any prior history of Acute Myeloid Leukemia (AML).
- Malignant or metastatic disease within the previous 12 months.
- Uncorrected red cell folate deficiency or vitamin B12 deficiency.
- Hepatic tumors.
- Radiation, chemotherapy, or cytotoxic therapy for non-MDS conditions in the previous 12 months.
- Known or suspected hypersensitivity to azacitidine or mannitol.
- Prior transplantation or cytotoxic therapy to treat MDS. Prior use of Revlimid and Thalomid allowed after 30 day washout.
- Serious medical illness likely to limit survival to less than or equal to 7 months.
- Treatment with androgenic hormones during the previous 14 days
- Active viral infection with known human immunodeficiency virus or vial hepatitis Type B or C.
- Treatment with other investigational drugs with the previous 30 days.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00102687
Start Date
January 1 2005
End Date
August 1 2008
Last Update
November 22 2019
Active Locations (31)
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1
Comprehensive Blood and Cancer Center, Research Department
Bakersfield, California, United States, 93309
2
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
3
Cancer Center of Colorado Springs, The Oncology Clinic, PC
Colorado Springs, Colorado, United States, 80907
4
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States, 80218