Clinical trial · Observational
A Multi-center Clinical Study of Zanubrutinib in Combination With First-line Chemoimmunotherapy in Patients With Grade 3A High-risk Follicular Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: At present, there is controversy about whether FL3a is treated as FL or DLBCL. Relevant studies have shown that compared with patients with FL3a grade 1\~2, they have unique immunohistochemical characteristics, and there are some differences in clinical features and outcomes. In patients with FL3a, the Ki-67 index is higher, the recurrence rate is higher, there is more histologic transformation, the prognosis is worse, and the likelihood of lymphoma-related death is higher. Bruton's tyrosine kinase (BTK) is a key kinase in the B-cell signaling pathway, and studies have shown that BTK inhibitors including zanubrutinib combined with traditional immunochemotherapy regimens may have a synergistic effect in the treatment of B-cell malignancies, and the combination has become one of the current clinical research directions. Aim: To assess the efficacy and safety of zanubrutinib in combination with first-line immunochemotherapy in high-risk patients with FL3a.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- CR
- timeFrame
- 2 years
- description
- complete response
Secondary outcomes (3)
- measure
- ORR
- timeFrame
- 2 years
- description
- ORR: the proportion of patients whose tumors shrink by 30% and remain in effect for more than 4 weeks.
- measure
- PFS of 2 years
- timeFrame
- 2 years
- description
- PFS of 2 years: the time from the start of treatment to the time when the patient has progressed on the disease or dies due to any cause in 2 years.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Age 18-70 years old (including 18 years old and 70 years old), ECOG score 0-2 points; 2. Confirmed diagnosis of follicular lymphoma with pathological grade of 3A (pathological report of three months before enrollment is acceptable) (Note: If there is any doubt about the pathological diagnosis, a domestic third-party consultation can be organized); 3. Treatment-naïve patients with indications for treatment; 4. Meet at least one of the criteria for high tumor burden in GELF; 5. Have not received other tumor-related treatments in the past; 6. Acceptable hematological indexes, no contraindications to chemotherapy; 7. Liver function: TBIL≤1.5×ULN; ALT or AST ≤2.5×ULN; Alkaline phosphatase ≤3×ULN in patients with non-bone invasion; 8. Renal function: serum creatinine ≤1.5×ULN; 9. Female and male patients of childbearing potential and their spouses are willing to use adequate contraception throughout the study period, and female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose; 10. Subjects voluntarily participated in the clinical trial, signed the informed consent form, and cooperated with the follow-up. Exclusion Criteria: * 1\. Refusal to collect blood specimens; 2. Previous allergy to any of the medications in the regimen; 3. Pregnant and lactating women; 4. Significant illness that, in the opinion of the investigator, can cause trial interference; 5. Combined with other tumors; 6. Presence of contraindications related to the treatment of the drug in the protocol; 7. Those with severe mental illness; 8. Participating in other clinical trials; 9. Prior treatment with anti-tumor therapy (such as radiotherapy, chemotherapy, hormonal therapy, biological therapy, immunotherapy); 10. Other serious diseases that may limit the subject's participation in this trial, such as: uncontrolled diabetes mellitus; Severe cardiac insufficiency (NYHA classification II or above); Acute coronary syndrome within the past 6 months; Coronary revascularization such as stenting, coronary artery bypass surgery, and other heart and large vessel related surgeries in the past 6 months; Severe arrhythmias include frequent premature ventricular episodes, ventricular tachycardia, rapid atrial fibrillation/atrial flutter, and severe bradycardia. Uncontrolled hypertension: systolic blood pressure \> 150 mmHg, diastolic blood pressure \> 100 mmHg. Gastric ulcer (gastric ulcer judged by the investigator to be at risk of perforation); Active autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, autoimmune thrombocytopenia, etc.); Severe respiratory diseases (such as obstructive pulmonary disease and history of bronchospasm), etc.; 11. In the opinion of the investigators, it is not suitable for enrollment; 12. Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer test is not within the normal reference value; Those who are positive for hepatitis C virus (HCV) antibody and positive for hepatitis C virus (HCV) RNA in peripheral blood; Those who are positive for human immunodeficiency virus (HIV) antibodies; Those who test positive for syphilis.
References
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