A Multi-center Clinical Study of Zanubrutinib in Combination With First-line Chemoimmunotherapy i… (NCT06742879) | Clinical Trial Compass
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A Multi-center Clinical Study of Zanubrutinib in Combination With First-line Chemoimmunotherapy in Patients With Grade 3A High-risk Follicular Lymphoma
China37 participantsStarted 2024-05-01
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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. Pre…