Alternative Dosing Regimens of Subcutaneous Azacitidine for Myelodysplastic Syndromes

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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 and dosing schedules.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Azacitidine

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.