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 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT02074657
Eligibility Criteria:
Inclusion Criteria:
1. Patients between 0 and 23 years of age with diagnosis of acute lymphoblastic leukemia, in second relapse situation, posttransplant relapse or refractary, or
2. Patients between 0 and 23 years of age with diagnosis of acute myeloblastic leukemia, relapsed or refractary. (Patient must meet inclusion criteria 1 or 2)
3. Lansky index \> 60%
4. Mild (\<2) functional organs alteration (hepatic, renal, respiratory) according to National Cancer Institute criteria (NCI CTCAE v4).
5. Left ventricular ejection fraction \> 39%
6. To grant informed consent in accordance with the current legal regulations.
7. Presence of a compatible haploidentical donor (father or mother or brother).
Exclusion Criteria:
1. Patients with history of bad therapeutical compliance
2. Patients not valid after psycho-social evaluation
3. Positive HIV serology
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
23 Years
Study:
NCT02074657
Study Brief:
Protocol Section:
NCT02074657