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:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT00513305
Eligibility Criteria:
Inclusion Criteria:
* The patient has confirmed acute myeloid leukemia (AML).
* The patient is unwilling or unable to tolerate conventional induction chemotherapy.
* The patient has no comorbid conditions that would limit life expectancy to less than 3 months.
* Patient must meet specific laboratory parameters for study inclusion.
Exclusion Criteria:
\- The patient has had previous cytotoxic chemotherapy for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
Previous treatment with low-dose cytarabine is not permitted.
* The patient has a QT interval outside of the protocol-specified range.
* The patient has laboratory values outside of protocol-specified ranges.
* The patient is concurrently treated with cytotoxic therapy, radiation, or investigational agents.
* The patient has uncontrolled, severe cardiovascular or pulmonary disease or other uncontrolled medical condition.
* The patient has known central nervous system involvement with AML.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT00513305
Study Brief:
Protocol Section:
NCT00513305