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 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT06891157
Eligibility Criteria:
Inclusion Criteria:
* Patients must meet all of the following inclusion criteria to be eligible for enrollment:
1. ≥18 years of age;
2. Diffuse large B-cell lymphoma diagnosed by pathological diagnosis according to WHO 2016 classification criteria;
3. Molecular subtyping, determined through high-throughput sequencing of pathological tissue or peripheral blood, is categorized as the "Other" subtype;
4. Immunohistochemistry revealed overexpression of MYC and BCL2: MYC ≥ 40%, BCL2 ≥ 50%;
5. Measurable lesions identified on cross-sectional imaging through diagnostic modalities (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) are defined as the presence of at least one two-dimensional lesion with a maximum cross-sectional diameter (GTD) ≥1.5 cm, irrespective of the short-axis diameter;
6. The Eastern Cooperative Oncology Group (ECOG) performance status score is ≤2；
7. Adequate hepatic function is defined as: total bilirubin (TBIL) ≤ 3 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 × ULN; alkaline phosphatase (ALP) ≤ 5 × ULN; serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 35 mL/min as calculated by the Cockcroft-Gault formula;
8. Voluntary participation with willingness to provide the aforementioned treatment data, accompanied by a signed and dated informed consent form.
Exclusion Criteria:
* Patients who meet any of the following criteria will be excluded from the study：
1. Currently enrolled in another clinical trial；
2. Received prior lymphoma treatment with alternative regimens before enrollment;
3. Presence of concurrent malignant tumors;
4. Deemed ineligible for participation by the investigator's judgment；
5. Presence of severe psychiatric or neurological disorders that may impair the ability to provide informed consent and/or affect the reporting or observation of adverse events；
6. Patients unable to comply with follow-up requirements；
7. Pregnant or lactating women, and patients of childbearing potential unwilling to use contraception;
8. Active infection or uncontrolled HBV (HBsAg positive and/or HBcAb positive and HBV DNA positive), HCV positive
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06891157
Study Brief:
Protocol Section:
NCT06891157