Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2025-12-24 @ 5:51 PM
NCT ID:
NCT00520468
Eligibility Criteria:
Inclusion Criteria:
1. Patients with MDS and \</= 10% blasts or International Prognostic Scoring System (IPSS) low or intermediate 1. No prior intensive chemotherapy or high-dose ara-C (\>/= 1g/m2). Prior cytokines, biologic therapies, targeted therapies, or single agent chemotherapy allowed. Procrit, G-CSF are allowed before therapy. Patients with blasts \< 5% must have an indication for therapy, such as transfusion needs, symptomatic anemia or Hb \< 11g/dl, platelets \< 100 x 10 9/L, or granulocytes \< 10 9/L.
2. Performance 0-2 (Eastern Cooperative Oncology Group (ECOG)). Adequate liver function (bilirubin of \< 2mg/dl) and renal function (creatinine \< 2mg/dl). Adequate cardiac functions (New York Heart Association (NYHA) cardiac III-IV excluded)
3. Signed informed consent
Exclusion Criteria:
1. Nursing and pregnant females are excluded. Women of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
2. Patients with active and uncontrolled infections.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00520468
Study Brief:
Protocol Section:
NCT00520468