A Multi-center Clinical Study of Zanubrutinib in Combination With First-line Chemoimmunotherapy i… (NCT06742879) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.