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 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07480850
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years;
* DLBCL confirmed by pathological diagnosis according to the WHO 2016 classification;
* PET-positive (Deauville score 4-5) according to Lugano response criteria after 3 cycles of first-line treatment;
* No history or evidence of central nervous system involvement;
* Adverse reactions from prior treatments have recovered to grade 1 or below (excluding clinically insignificant reactions such as hair loss);
* ECOG performance status score ≤ 2;
* Adequate bone marrow, kidney, liver, respiratory, and cardiac function: absolute neutrophil count ≥ 1000/μL; platelet count ≥ 75,000/μL; absolute lymphocyte count ≥ 100/μL; creatinine clearance ≥ 60 mL/min; ALT and AST ≤ 2.5 times the upper limit of normal; total bilirubin ≤ 1.5 mg/dL (except for Gilbert's syndrome); cardiac echocardiography showing ejection fraction ≥ 50% with no pericardial effusion (small or physiological effusions excluded); no clinically significant serosal effusions; baseline oxygen saturation \> 92%;
* The subject is able to understand the study protocol, is willing to participate in this study, and provides written informed consent.
Exclusion Criteria:
* History of malignant tumors, excluding non-melanoma skin cancers or carcinoma in situ (cervix, bladder, breast), unless the disease has been in remission for at least 3 years;
* Uncontrolled fungal, bacterial, viral, or other infections requiring intravenous anti-infective therapy;
* Human immunodeficiency virus (HIV) infection, or acute/chronic active hepatitis B or C infection;
* Malignant cells detectable in cerebrospinal fluid or active CNS lymphoma;
* History of myocardial infarction, coronary artery bypass graft, or stent implantation within 12 months prior to enrollment;
* History of deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment;
* Female patients who are pregnant or breastfeeding, as determined by the investigator;
* Inability of the subject to complete the study protocol or visits;
* Presence of uncontrollable infection;
* Currently participating in interventional study treatment, or having received other investigational drugs within 4 weeks prior to first dose (previous treatment with cetuximab, oxaliplatin, and gemcitabine is included);
* Any other condition that the investigator deems the patient unsuitable for this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07480850
Study Brief:
Protocol Section:
NCT07480850