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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT05599360
Eligibility Criteria:
Inclusion criteria:
1. Diagnosis of AML (\>20% blasts in blood or BM)
2. Favorable or intermediate risk cytogenetics
Exclusion criteria:
1. Acute promyelocytic leukemia with recurring translocations involving Retinoic Acid Receptor Alpha (RARA)
2. Acute leukemias of ambiguous lineage
3. Therapy-related myeloid neoplasms
4. Background of myelodysplastic syndrome or myeloproliferative neoplasm
5. FLT3-Internal tandem duplications (ITD) mutation with any allelic ratio
6. AML with Adverse cytogenetic risk (ELN 2017)
7. Eastern Cooperative Oncology Group (ECOG) performance status 3-4
8. Previous treatment with radiation therapy or cytotoxic chemotherapy (treatment with corticosteroids or hydroxyurea will not exclude the patient)
9. Age\<18 or \>70
10. Serum creatinine ≥ 2.0 mg/dl or creatinine clearance \< 50 ml/min within 14 days of registration
11. Direct bilirubin ≥2.0 g/dl, or alkaline phosphatase/ serum glutamic-oxaloacetic transaminase (SGOT) \> 4xupper limit of normal within 14 days of registration
12. Left ventricular ejection fraction (LVEF)\<45%
13. Pregnant or breastfeeding women
14. Blastic transformation of chronic myelogenous leukemia (CML)
15. Secondary AML (defined as prior chemotherapy-induced or evolved from myelodysplastic syndrome or myeloproliferative neoplasm)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05599360
Study Brief:
Protocol Section:
NCT05599360