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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07481669
Eligibility Criteria:
Inclusion Criteria:
1. Histopathologically confirmed systemic non-Hodgkin lymphoma at initial diagnosis and meets one of the following:
1. CNS IPI score (4-6 points)
2. kidney or adrenal gland involvement
3. testis or breast involvement
4. primary cutaneous DLBCL, leg type
2. CR or PR after induction therapy
3. Age 18-70 years.
4. Adequate renal, hepatic, pulmonary, hematologic, and cardiac function:
* Creatinine clearance (Cockcroft-Gault) ≥ 50 mL/min / serum creatinine ≤ 1.5 mg/dL
* ALT and AST \< 2.5 × upper limit of normal (ULN)
* Total bilirubin \< 1.5 × ULN
* Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
* Platelet count ≥ 100 × 10⁹/L
* Left ventricular ejection fraction ≥ 50%; no clinically significant pericardial effusion or ECG abnormalities
* No clinically significant pleural effusion
* Baseline oxygen saturation ≥ 95% at rest on room air
5. Negative serum or urine pregnancy test for females of childbearing potential (females who have undergone sterilization or are postmenopausal for ≥ 2 years are considered non childbearing). All patients must practice effective contraception during study treatment.
6. Able to comply with the study protocol per investigator judgment.
7. Voluntary participation, understanding study procedures, and provision of written informed consent; For illiterate patients (potentially vulnerable population), a literate family member must be present and provide written consent.
Exclusion Criteria:
1. Diagnosis of primary central nervous system lymphoma (PCNSL).
2. Concurrent malignancy or life-threatening disease; or prior malignancy cured \< 2 years.
3. Grade ≥ 2 mucositis.
4. Congestive heart failure, uncontrolled hypertension, or unstable cardiovascular disease.
5. Uncontrolled infection.
6. Uncontrolled progressive disease during the study.
7. Prior allogeneic hematopoietic stem cell transplantation.
8. Any condition that may interfere with safety or efficacy assessment.
9. Severe hypersensitivity to any study drug.
10. Pregnant or breastfeeding females.
11. Males or females unwilling to use contraception from consent signature until 6 months after completion of study treatment.
12. Unlikely to complete all required study visits/procedures (including follow up) per investigator judgment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07481669
Study Brief:
Protocol Section:
NCT07481669