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:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT01716793
Eligibility Criteria:
Inclusion Criteria:
* Patients with newly diagnosed AML, classified by FAB criteria
* Age not superior to 60 years
* Verbal informed consent for the chemotherapy and written for the mobilization and stem cell transplantation
Exclusion Criteria:
* Patients treated previously for its AML with other chemotherapy different from hydroxyurea
* Acute promyelocytic leukemia (M3)
* Chronic myeloid leukemia in blastic crisis
* Leukemias appearing after other myeloproliferative processes
* Leukemias surviving after myelodysplastic syndromes with more than 6 months of evolution
* Presence of other neoplastic disease in activity
* Secondary AML which had appeared after cured malignancies (for instance Hodgkin disease) and those who are still exposed to alkylant agents or radiation
* Renal and hepatic abnormal function with creatinine values and/or bilirubin two times higher than the normal threshold, except when this alteration could be attributed to the leukemia
* Patients with a fraction of ejection very low (inferior to 40%), symptomatic cardiac insufficiency or both
* Patients with a grave concomitant neurological or psychiatric disease
* Positivity of HIV (donor and/or receptor)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01716793
Study Brief:
Protocol Section:
NCT01716793