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 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT05334693
Eligibility Criteria:
Inclusion Criteria:
Patients:
* primary intermediate risk AML in molecular complete remission;
* primary high risk AML in molecular complete remission awaiting unrelated HSCT;
* Karnofsky or Lansky performance scale greater or equal to 70;
* written informed consent.
Donors:
* haploidentical family donor;
* donor suitable for cell donation and apheresis according to standard criteria;
* written informed consent.
Exclusion Criteria:
Patients:
* uncontrolled infection;
* severe hepatic dysfunction: SGOT or SCPT \>=5x upper limit of normal for age;
* positive serology for human immunodeficiency virus (HIV).
Donors:
* pregnancy;
* positive serology for HIV, hepatitis B or C.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
21 Years
Study:
NCT05334693
Study Brief:
Protocol Section:
NCT05334693