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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT01518556
Eligibility Criteria:
Inclusion Criteria:
* Patient has been fully informed, has complete understanding fo this study, and has given voluntary written informed consent to comply with the protocol requirements.
* previously untreated de novo or secondary acute myeloid leukemia, including biphenotypic leukemia
* age between 20 and 65 years
* adequate organ functions, unless these abnormalities are attributable to leukemia
* left ventricular ejection fraction \> 45%
* serum creatinine \< 1.5 x upper limit of normal
* total bilirubin \< 1.5 x upper limit of normal
* alanine transferase and aspartate transferase \< 2.5 x upper limit of normal if liver function abnormality is attributable to underlying leukemia, ALT and AST \< 5 x upper limit of normal
* Eastern Cooperative Oncology Group performance status score of 0 to 2
Exclusion Criteria:
* hypersensitivity to the study drug
* any other malignancies within 3 years, except for cured non-melanoma skin cancer and curatively treated in situ carcinoma of the cervix
* New York Heart Association class III or IV heart failure, severe uncontrolled cardiac disease or myocardial infarction within the previous 6 months prior to the date of consent
* incapable of giving voluntary written informed consent to comply with the protocol requirements, which results from drug or alcohol intoxication, or neurological or psychiatric disorders
* pregnant or breastfeeding
* recent chemotherapy within 4 weeks prior to this study treatment
* acute promyelocytic leukemia
* current or recent treatment with any other investigational medicinal product within 28 days prior to this study enrollment
* unsuitable for this study, in the investigator's opinion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT01518556
Study Brief:
Protocol Section:
NCT01518556