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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT04337593
Eligibility Criteria:
Inclusion Criteria:
* Pathology confirmed diagnosis of NK/T-cell lymphoma.
* Previously treated with pegaspargase-based regimens.
* PET-CT or MRI scan with at least one measurable lesion.
* ECOG score of 0-3 points.
* The lab tests within 1 week before enrollment meets the following:
* Blood routine: Hb≥80g/L, PLT≥50×10e9/L.
* Liver function: ALT, AST, TBIL≤2 times the upper limit of normal.
* Renal function: Cr is normal.
* Coagulation: plasma fibrinogen≥1.0g/L.
* Cardiac function: LVEF≥50%, ECG is normal
* Sign the informed consent form.
* Voluntary compliance with research protocols.
Exclusion Criteria:
* Patients with a history of pancreatitis.
* Active infection requires ICU treatment.
* Concomitant HIV infection or active infection with HBV, HCV.
* Serious complications such as fulminant DIC.
* Significant organ dysfunction:
* respiratory failure
* NYHA classification≥2 chronic congestive heart failure
* decompensation Hepatic or renal insufficiency
* high blood pressure and diabetes that cannot be controlled
* cerebral vascular events within the past 6 months.
* Pregnant and lactating women.
* Had a history of autoimmune diseases, and disease was active now. Those who were known to be allergic to drugs in the study regimen.
* Patients with other tumors who require treatments within 6 months.
* Other experimental drugs are being used.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04337593
Study Brief:
Protocol Section:
NCT04337593