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 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT00788892
Eligibility Criteria:
Inclusion Criteria:
* Age ≥60 and \<76 years at the time of diagnosis of AML
* Pathological confirmation of AML
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Able to adhere to the study visit schedule and other protocol requirements
* Laboratory values fulfilling the following:
Serum creatinine \< 2.0 mg/dL Serum total bilirubin \< 2.0 mg/dL Serum alanine aminotransferase or aspartate aminotransferase \< 150 IU/liter Note: If elevated liver enzymes are related to disease; contact medical monitor to discuss.
* Cardiac ejection fraction \> 50% by echocardiography or MUGA scan
Exclusion Criteria:
* Patients with locally advanced or metastatic solid tumors ≤5 years from initial diagnosis are excluded. (Patients with locally advanced or metastatic solid tumors \>5 years from initial diagnosis, for whom the investigator has no clinical suspicion of active disease for \>2 years before randomization are eligible)
* Prior treatment for AML; only hydroxyurea is permitted (see below)
* Acute promyelocytic leukemia \[t(15;17)\] or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization
* Patients with a prior anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent)
* Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent
* Administration of any antineoplastic therapy within 4 weeks of the first CPX-351 dose; in the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment
* Clinical evidence of active CNS leukemia
* Patients with history of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Class III or IV staging
* Active and uncontrolled infection. Patients with an infection receiving treatment with antibiotics may be entered into the study if they are afebrile and hemodynamically stable for 72 hrs.
* Current evidence of invasive fungal infection (blood or tissue culture); HIV or active hepatitis C infection
* Hypersensitivity to cytarabine, daunorubicin or liposomal products
* History of Wilson's disease or other copper-related disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
75 Years
Study:
NCT00788892
Study Brief:
Protocol Section:
NCT00788892