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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT00780104
Eligibility Criteria:
Inclusion Criteria:
* Must have histologic evidence of advanced myeloid leukemias defined as one of the following: primary refractory non-M3 AML; relapsed non-M3 AML; secondary AML; intermediate or poor prognosis de novo AML in patients who are \>= 60 years old
* \>= 18 years of age
* ECOG performance status of 0, 1
* Able to consume oral medication
* Initial laboratory values: creatinine \<= 2.0 mg/dL; total or direct bilirubin \<= 1.5/dL; SGPT(ALT) \<= 3xULN; negative pregnancy test for women with child-bearing potential
* Ejection fraction of \>= 45%
Exclusion Criteria:
* Subjects with FAM B3
* Must not be receiving chemotherapy (except Hydroxyurea)
* Not receiving growth factors, except for erythropoietin
* Subjects with a "currently active" second malignancy other than non-melanoma skin cancers
* Subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, MI within the last 6 months or uncontrolled cardiac arrhythmia
* Subjects taking diltiazem
* Subjects who require HIV protease inhibitors or those with AIDS-related illnesses
* No evidence of cerebellar dysfunction at baseline or during prior cytarabine therapy
* Not pregnant or breastfeeding
* Uncontrolled infection
* Subjects taking Carbamazepine, Rifabutin, Rifampin, Rifapentine, St. John's wort, Clarithromycin, Cyclosporine, Diltiazem, Erythromycin, Telithromycin, Verapamil, Tacrolimus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00780104
Study Brief:
Protocol Section:
NCT00780104