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:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT05367856
Eligibility Criteria:
Inclusion Criteria:
1. According to world Health Organization (WHO) classification of disease, T cell lymphoma (excepted IPI 0-1 point ALK+ anaplastic cell lymphoma) was confirmed by histology, CR or PR after first-line treatment;
2. 18≤ age ≤65 years old, male or female;
3. ECOG score 0-1;
4. No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) :
* White blood cell count ≥3.0×109/L, absolute neutrophil count ≥1.5×109/L, Hemoglobin ≥90g/L, platelet ≥75×109/L;
* Total bilirubin ≤1.5× upper normal value (ULN);
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× upper normal value (ULN);
* Creatinine clearance was 44-133 mmol/L;
5. No cardiac dysfunction;
6. Life expectancy over 3 months;
7. The subject or his/her legal representative must provide written informed consent prior to conducting a special study examination or procedure.
Exclusion Criteria:
1. Central nervous system lymphoma was excluded;
2. Suffering from serious complications or severe infection;
3. A history of other malignant tumors within 5 years, excluding early tumors treated for curative purposes;
4. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.;
5. HBsAg, HCV or HIV positive. Positive HBV and HCV serology is allowed, but DNA/RNA testing must be negative;
6. Laboratory test value during screening;
① Neutrophils \<1.5×109/L; Platelet \<75×109/L;
② Bilirubin was 1.5 times higher than the normal upper limit, transaminase was 2.5 times higher than the normal upper limit;
③ The creatinine level is higher than 1.5 times the upper limit of normal value;
7. Left ventricular ejection fraction ≦ 50%;
8. Other concurrent and uncontrolled medical conditions considered by the investigator would affect the patient's participation in the study;
9. Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol;
10. Pregnant or lactating women;
11. The researcher judged that the patients were not suitable for this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05367856
Study Brief:
Protocol Section:
NCT05367856