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 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT01641250
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, \>/= 18 years of age
* Histologically or cytologically confirmed, acute myelogenous leukemia (all subtypes except acute promyelotic leukemia) according to WHO criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* All non-hematological adverse events of any prior chemotherapy, surgery, or radiotherapy must have resolved to NCI-CTC AE Grade \< 2, except alopecia
* Adequate hepatic and renal function
* Patient must be willing to submit blood and bone marrow samples for PK and PD analyses and exploratory biomarkers
Exclusion Criteria:
* Patients receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 14 days of first receipt of study drug, with the exception of hydroxyurea
* History of allergic reactions attributed to components of cytarabine and/or the formulated product
* Current evidence of CNS leukemia
* Increased QTc interval (QTc \> 470 ms), baseline resting bradycardia \< 45 beats per minute, or baseline resting tachycardia \< 100 beats per minute
* Family history of long QT syndrome or other risk factors for torsades de pointes, and/or the use of concomitant medications that prolong QT/QTc interval
* Uncontrollable intercurrent illness
* Pregnant or breast-feeding women
* HIV-positive patients receiving anti-retroviral therapy
* Patients who refuse to potentially receive blood products and/or have a hypersensitivity to blood products
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01641250
Study Brief:
Protocol Section:
NCT01641250