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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT03154918
Eligibility Criteria:
Inclusion Criteria:
1. diagnosis of ENKL defined by World Health Organization classification 2008;
2. age above 18 years;
3. Eastern Cooperative Oncology Group performance status of 0-3;
4. adequate organ function defined as: total bilirubin≤2 times the upper limit of normal; alanine aminotransferase and aspartate aminotransferase levels≤2.5 times the upper limit of normal; serum creatinine≤1.5 mg/dL; creatinine clearance ≥50 mL/minute and normal electrocardiogram results.
Exclusion Criteria:
1. uncontrolled infection;
2. pregnant or lactating women;
3. contraindication to one of the trial drugs (eg. anaphylaxis to L-asparaginase);
4. any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03154918
Study Brief:
Protocol Section:
NCT03154918