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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT02686593
Eligibility Criteria:
Inclusion Criteria:
1. Relapsed or refractory acute myeloid leukemia (AML) after one first-line chemotherapy regimen
2. Patients aged 18 - 65 inclusively
3. European Cooperative Oncology Group (ECOG) performance status of less than 2
Exclusion Criteria:
1. Patients aged less than 18 or above 65
2. ECOG performance status of 2 or more
3. Acute promyelocytic leukaemia
4. Uncontrolled active infection
5. Uncontrolled arrhythmia
6. Altered renal dysfunction with serum creatinine \> 1.5 x ULN and/or creatinine clearance \< 50 mL/min
7. Significant neurologic (grade \> 2) or psychiatric disorder, dementia or seizures
8. Clinical symptoms suggesting active central nervous system leukemia
9. Severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock or disseminated intravascular coagulation
10. Patients with known HIV, Hepatitis B or C infection or history of cirrhosis
11. Patients Significant hepatic dysfunction: Direct bilirubin \> 1.5 x upper limit of normal (ULN) for age; ALT or AST \> 3 x upper limit of normal (ULN) for age; Lipase \> 2.0 x upper limit of normal (ULN) for age
12. Females of childbearing potential must have a negative pregnancy test
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02686593
Study Brief:
Protocol Section:
NCT02686593