Alternative Dosing Regimens of Subcutaneous Azacitidine for Myelodysplastic Syndromes
Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Comprehensive Blood and Cancer Center, Research Department
- Tower Cancer Research Foundation
- Cancer Center of Colorado Springs, The Oncology Clinic, PC
- Rocky Mountain Cancer Centers, LLP
- Washington Cancer Institute
- Florida Cancer Institute
- Cancer Centers of Florida, P.A.
- Joliet Oncology-Hematology Associates, Ltd.
- Oncology/Hematology Associates of Central Illinois, PC
- Central Indiana Cancer Centers
- Hematology & Oncology Specialists LLC
- Great Lakes Cancer Institute Breslin Cancer Center
- The Center for Cancer Care and Research
- Hackensack University Medical Center
- Greater Dayton Cancer Center
- Western Pennsylvania Cancer Institute
- Oncology Services of Aberdeen
- Avera Cancer Institute Leukemia-Bone Marrow Transplant Center
- McLeod Cancer and Blood Center
- The Sarah Cannon Research Institute
- Texas Oncology, P.A.
- Texas Cancer Center at Medical City
- Texas Oncology, PA
- San Antonio Tumor & Blood Clinic
- Cancer Care Centers of South Texas - HOAST
- Virginia Oncology Associates - Lake Wright Cancer Center
- Highline Medical Oncology
- Puget Sound Cancer Center
- Puget Sound Cancer Center
- Cancer Care Northwest
- Northwest Cancer Specialists, P.C.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Aza-5
Aza-5-2-2
Aza-5-2-5
Maintenance Aza 5 days q 4 weeks
Maintenance Aza 5 days q 6 weeks
Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
Azacitidine administered subcutaneously at 75mg/m^2 for 5days with 2 days off, then for an additional 2 days, on a 28 day cycle.
Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks.
Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks.