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 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
NCT ID:
NCT00104468
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of acute myelogenous leukemia (AML) refractory to prior therapy and/or unlikely to benefit from known therapies.
* Subjects must have adequate organ and immune function as indicated by the following laboratory values: \*Creatinine clearance ≥5 L/hr (83mL/min), \*Total Bilirubin ≤2.0 mg/dL (≤34.2 µmol/L), \*AST(SGOT) and ALT(SGPT) ≤3 x ULN
Exclusion Criteria:
* Clinical evidence of active central nervous system (CNS) leukemic involvement
* Active and uncontrolled infection
* Uncontrolled medical problems unrelated to the malignancy that impair their ability to give informed consent or unacceptably reduce the safety of the proposed treatment
* Neurologic or psychiatric disorders that would interfere with informed consent or study follow-up
* Known or suspected intolerance or hypersensitivity to the investigational new drug or closely related compounds like lamivudine, and/or a recent history of alcohol or other substance abuse.
* Also not eligible are subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrollment.
* Females with a positive pregnancy test at screening or subjects that have previously been enrolled into this study and subsequently withdrew.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00104468
Study Brief:
Protocol Section:
NCT00104468