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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT02605460
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL), candidates to HSCT
* Allogeneic HSCT: High risk AML in first complete remission (CR), AML in second CR, and ALL in first or second CR with a matched or half-matched (haploidentical) related or unrelated donor
* Autologous HSCT: Intermediate risk AML in first CR, ALL in first or second CR without a donor
* Normal liver function enzyme tests
* Preserved renal function
* Eastern Cooperative Oncology Group score ≤2 or Karnofsky ≥80%
* Left ventricle ejection fraction (LVEF) \>40%
* Hemoglobin (Hb) ≥ 10 g/dl, Absolute Neutrophil Count ≥ 1 x 103/mm3, and Platelets ≥ 100,000 /µL
* Signed Informed Consent
Exclusion Criteria:
* Patients not willing to participate or to sign the informed consent
* Patients who do not meet the inclusion criteria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02605460
Study Brief:
Protocol Section:
NCT02605460