Study of Azacitidine in patients with a type of blood cancer
- Conditions
- Health Condition 1: null- Myelodysplastic syndrome
- Registration Number
- CTRI/2012/07/002836
- Lead Sponsor
- ATCO Pharma Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
•Male and female MDS patients ï?³ 18 years of age with a diagnosis of FAB criteria-defined refractory anemia (RA), RA with ringed sideroblasts (RARS). RA with excess blasts (RAER), RA with excess blasts in transformation (RAEB-T), or chronic myelomonocytic leukemia (CMML).
•Life expectancy more than 7 months.
•RA or RARS patients must meet at least one of the following criteria: hemoglobin lower than 11.0 g/dL with requirements for at least one RBC transfusion every 28 days; thrombocytopenia with platelet count lower than 100 X 109/L, or neutropenia with absolute neutrophil count lower than 1.5 X 109 /L
•Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
•Laboratory screening
•No erythropoietin, corticosteroids, interferon, or retinoids usage within 1 month before study
•Patients willing to give informed consent
•No prior history of leukemia
•Patients must be willing to practice birth control during and for 6months after treatment with Azacitidine
1.Patients with secondary MDS, a history of AML or other malignant disease.
2.Patients with uncorrected red cell folate deficiency or vitamin B12 deficiency.
3.Patients with a history of severe cardiac or pulmonary disease, or received radiation therapy, chemotherapy, or other investigational drugs within the previous 30 days.
4.Female patients, who are pregnant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method