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 @ 2:33 AM
Ignite Modification Date:
2025-12-25 @ 2:33 AM
NCT ID:
NCT06513234
Eligibility Criteria:
Inclusion Criteria:
* • Age ≥18 years, gender unrestricted;
* Histopathologically confirmed CD20-positive marginal zone lymphoma including MALT, SMZL, NMZL;
* MZL that has progressed, recurred, or is unsuitable for local treatment after previous local therapy (local treatments include surgery, radiotherapy, Helicobacter pylori treatment, hepatitis C treatment);
* ECOG performance status score of 0-2.
* Major organ functions meet the following criteria: a) Complete blood count: Absolute neutrophil count ≥1.5×10\^9/L, platelets ≥75×10\^9/L, hemoglobin ≥75g/L; if accompanied by bone marrow involvement, absolute neutrophil count ≥1.0×10\^9/L, platelets ≥50×10\^9/L, hemoglobin ≥50g/L; b) Blood biochemistry: Total bilirubin ≤1.5 times the upper limit of normal (ULN), AST or ALT ≤2 times ULN; serum creatinine ≤1.5 times ULN; serum amylase ≤ULN; c) Coagulation function: International normalized ratio (INR) ≤1.5 times ULN.
* Life expectancy ≥3 months;
* Voluntarily sign a written informed consent form before the trial screening.
Exclusion Criteria:
* Currently or previously having other malignant tumors, unless radical treatment has been performed and there is evidence of no recurrence or metastasis within the last 5 years;
* Lymphoma involving the central nervous system or transforming into a higher grade;
* Having uncontrollable or significant cardiovascular diseases, including: a) New York Heart Association (NYHA) class II or above congestive heart failure, unstable angina, myocardial infarction within 6 months before the first administration of the study drug, or arrhythmias requiring treatment at the time of screening, with a left ventricular ejection fraction (LVEF) \<50%; b) Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy); c) A history of clinically significant QTc interval prolongation, or a QTc interval \>470ms in females and \>450ms in males during the screening period; d) Subjects with symptomatic or medication-requiring coronary artery heart disease; e) Subjects with difficult-to-control hypertension (despite lifestyle improvements and the use of reasonable, tolerable, and adequate doses of one or three or more antihypertensive drugs \[including diuretics\] for more than 1 month, blood pressure is still not at the standard, or it is only effectively controlled when taking four or more antihypertensive drugs).
* Active bleeding within 2 months before screening, or currently taking anticoagulant drugs, or the investigator believes there is a definite bleeding tendency;
* Active infection or uncontrolled HBV (positive for HBsAg and/or HBcAb with positive HBV DNA titer), positive for HCV Ab, HIV/AIDS, or other serious infectious diseases.
* Any other conditions deemed unsuitable for participation in this trial by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06513234
Study Brief:
Protocol Section:
NCT06513234