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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT04460508
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 to 75 years;
2. Patients with primary malignant lymphoma confirmed by histopathology or immunomolecular biology and requiring treatment with multi-cycle high-intensity chemotherapy regimen;
3. ECOG performance status ≤ 1;
4. ANC ≥1.5×109/L, PLT≥80×109 /L, Hb≥ 75g/L, WBC ≥3.0×109/L;
5. Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment;
6. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedul.
Exclusion Criteria:
1. Lymphoma central involvement;
2. Recipients of hematopoietic stem cell transplantation or organ transplantation;
3. Currently conducting clinical trials of other drugs;
4. There is an uncontrollable infection with body temperature ≥38℃;
5. liver function examination: total bilirubin (TBIL., alanine aminotransferase (ALT. and ascetic aminotransferase (AST. were all 2.5 times the upper limit of the normal value of \>; if they were caused by liver metastasis, the upper limit of the normal value of \> was 5 times;Renal function test: serum creatinine (Cr. \>2 times the upper limit of normal value
6. Patients with serious chronic diseases of heart, kidney, liver and other important organs;
7. Patients with severe uncontrolled diabetes;
8. Pregnant or lactating female patients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04460508
Study Brief:
Protocol Section:
NCT04460508