Health Condition 1: null- Myelodysplastic syndrome
Conditions
Interventions
Intervention1: Azacitidine: Dose 75 mg per sq meter
Frequequency once daily for 7 days in 4-6 months cycle
Control Intervention1: Best supportive care: Blood Products and antibiotics
Sponsors
NATCO Pharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: •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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematologic improvement criteria and transfusion independence rateTimepoint: After 1st,2nd,3rd,4th,5th and 6th cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| SafetyTimepoint: Continuous assessment | — |
Countries
India
Contacts
Public ContactDr MB Agarwal
Haematology Centre
Outcome results
None listed