Alternative Dosing Regimens of Subcutaneous Azacitidine for Myelodysplastic Syndromes

Completed · Phase 2

Conditions studied: Myelodysplastic Syndromes

In brief

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 and dosing schedules.

Key facts

Study ID

NCT00102687

Run by

Celgene

People needed

151

Starts

2005-01-01

Expected to finish

2008-08-01

Last updated by the study team

2019-11-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Comprehensive Blood and Cancer Center, Research Department — Bakersfield, California, United States
• Tower Cancer Research Foundation — Beverly Hills, California, United States
• Cancer Center of Colorado Springs, The Oncology Clinic, PC — Colorado Springs, Colorado, United States
• Rocky Mountain Cancer Centers, LLP — Denver, Colorado, United States
• Washington Cancer Institute — Washington D.C., District of Columbia, United States
• Florida Cancer Institute — New Port Richey, Florida, United States
• Cancer Centers of Florida, P.A. — Ocoee, Florida, United States
• Joliet Oncology-Hematology Associates, Ltd. — Joliet, Illinois, United States
• Oncology/Hematology Associates of Central Illinois, PC — Peoria, Illinois, United States
• Central Indiana Cancer Centers — Indianapolis, Indiana, United States
• Hematology & Oncology Specialists LLC — Metairie, Louisiana, United States
• Great Lakes Cancer Institute Breslin Cancer Center — Lansing, Michigan, United States
• The Center for Cancer Care and Research — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Greater Dayton Cancer Center — Kettering, Ohio, United States
• Western Pennsylvania Cancer Institute — Pittsburgh, Pennsylvania, United States
• Oncology Services of Aberdeen — Aberdeen, South Dakota, United States
• Avera Cancer Institute Leukemia-Bone Marrow Transplant Center — Sioux Falls, South Dakota, United States
• McLeod Cancer and Blood Center — Johnson City, Tennessee, United States
• The Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Texas Oncology, P.A. — Bedford, Texas, United States
• Texas Cancer Center at Medical City — Dallas, Texas, United States
• Texas Oncology, PA — Fort Worth, Texas, United States
• San Antonio Tumor & Blood Clinic — Fredericksburg, Texas, United States
• Cancer Care Centers of South Texas - HOAST — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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