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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT01723657
Eligibility Criteria:
Inclusion Criteria:
* Patients with newly diagnosed AML, classified using OMS criteria.
* Patients with 70 years old or younger.
Exclusion Criteria:
* Patients previously treated for the AML with chemotherapy different from hidroxiurea.
* Acute promyelocytic leukemia with t(15;17).
* Cronic mieloid leukemia in blastic crisis.
* Leukemias that appear after other myeloproliferative processes.
* Leukemias that survive after myelodysplasic syndromes of more than 6 months of evolution.
* Presence of other neoplasic disease in activity.
* Secondary AML which appears after cured malignant disease (for instance, Hodgking disease), and those who are still exposed to alkilant agents or radiation.
* Abnormal renal and hepatic functions with creatinin and/or bilirrubine 2 times higher than the normal threshold, except when the alteration should be attributed to the leukemia.
* Patient with an ejection fraction below 40%, symptomatic cardiac deficiency or both.
* Patients with neurological or concomitant psychiatric disease.
* Positivity by HIV.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01723657
Study Brief:
Protocol Section:
NCT01723657