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 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT06959732
Eligibility Criteria:
Inclusion Criteria:
Patients must meet all of the following criteria to be eligible:
1\. Histologically confirmed CD20-positive FL (grades 1, 2, or 3a), diagnosed according to the WHO 2022 criteria; 2, Clear indication for treatment: symptoms affecting normal work and life; end-organ dysfunction; cytopenia due to bone marrow involvement by lymphoma; bulky disease (per GELF criteria); persistent or rapidly progressive disease; 3. No prior systemic therapy for lymphoma; 4. Age 18-80 years; 5. Eastern cooperative oncology group (ECOG) performance status (PS) \< 2; 6. Expected survival \> 2 years; 7. At least one measurable lesion with a longest diameter ≥ 1.5 cm or extranodal lesion ≥ 1 cm; 8. Willingness to participate in the study and comply with treatment and follow-up.
Exclusion Criteria:
Patients will be excluded if they meet any of the following criteria:
1. Pregnant or breastfeeding women;
2. Abnormal liver or kidney function, defined as: serum direct/indirect bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), or serum creatinine \> 2 × upper limit of normal (ULN); creatinine clearance \< 60 mL/min (unless due to lymphoma involvement);
3. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months;
4. Absolute neutrophil count (ANC) \< 1.5 × 10⁹/L, platelets \< 75 × 10⁹/L, or hemoglobin \< 70 g/L (unless due to bone marrow involvement by lymphoma);
5. Long-term use of strong or moderate CYP3A inducers;
6. Known hypersensitivity to any component of the study drug;
7. Other active malignancies, except: cured non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ, or other malignancies with disease-free survival \> 5 years;
8. Severe concurrent infections;
9. Drug abuse, medical, psychological, or social conditions that may interfere with study participation or result evaluation;
10. Investigator-deemed ineligibility for the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06959732
Study Brief:
Protocol Section:
NCT06959732