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 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT00195104
Eligibility Criteria:
Inclusion Criteria:
* Histologic diagnosis of high-risk MDS (IPSS int-2).
* No prior cytotoxic therapy for MDS or AML (patients may have received prior therapy with hematopoietic growth factors, immunomodulatory agents or 5-azacitidine).
Exclusion Criteria:
* Pregnant or lactating women.
* Absolute QT interval \>460 msec in the presence of serum potassium and magnesium values within the normal range.
* Concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents.
* Uncontrolled or severe cardiovascular or pulmonary disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00195104
Study Brief:
Protocol Section:
NCT00195104