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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT02319135
Eligibility Criteria:
Inclusion Criteria:
1. \- Having voluntarily given informed consent before performing any test that is not part of
routine care of patients.
2. \- Age greater than or equal to 65.
3. \- Morphological diagnosis of non-promyelocytic AML according to the WHO criteria.
4. \- Newly diagnosed AML.
5. \- ECOG performance status \<4.
6. \- Ability and willingness to comply with the schedule of study visits.
Exclusion Criteria:
1. \- Genetic diagnosis of acute promyelocytic leukemia.
2. \- Patients with AML secondary to myelodysplastic syndrome (MDS) or chronic myeloproloferative syndrome who have been previously treated with antileukemic agents
(hypomethylating or standard chemotherapy). Treatment with hydroxyurea prior to randomization is allowed.
3. \- Serum creatinine ≥ 250 mmol / l (≥ 2.5 mg/dL) (unless attributed to AML).
4. \- Bilirubin, alkaline phosphatase or ALT \> 5 times the value of the upper limit of normal (unless attributed to AML) .
5. \- Presence of an active and/or non controlled pathology different to AML which is severe and life-threatening, that in the investigator's opinion, prevents the subject participation in the study.
6. \- Other active concomitant malignancy or whose remission is less than one year from the screening day (except carcinoma in situ).
7. \- Presence of any psychiatric illness or medical condition that, in the investigator's opinion, prevents the subject participation in the study.
8. \- Life expectancy less than X months.
9. \- Inability of the patient or his legal representative to understand and voluntarily sign the informed consent form.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT02319135
Study Brief:
Protocol Section:
NCT02319135