NCT06553352 Zanubrutinib in Combination With Obinutuzumab (ZO) for Newly Diagnosed Follicular Lymphoma
| NCT ID | NCT06553352 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital of Xiamen University |
| Condition | Follicular Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 39 participants |
| Start Date | 2024-03-31 |
| Primary Completion | 2026-04-20 |
Trial Parameters
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Brief Summary
To evaluate the efficacy and side effects of Zanubrutinib combined with Obinutuzumab (ZO) in the treatment of newly diagnosed follicular lymphoma.
Eligibility Criteria
Inclusion Criteria: 1. Age: ≥18 years old and gender-neutral; 2. Follicular lymphoma definitively diagnosed according to the REAL/WHO classification, stage II-IV requiring treatment according to the GELF code; 3. ECOG score 0-2; 4. Lymphoma efficacy evaluation criteria using Lugano 2014 Lymphoma must have at least one measurable or evaluable lesion: signed informed consent, subjects recruited based on inclusion and exclusion criteria, etc History taking and pre-treatment baseline examination and registration on case report form (CRF) ZO regimen of chemotherapy for 6 cycles, followed by zebrutinib monotherapy orally for 6 months, with observation of toxicities Follow-up assessment (including) Follow-up evaluation (including safety) \<Blood, biochemistry, B2-MG, neck, chest and abdomen CT plain + enhanced, questionnaire\> Follow-up evaluation (including safety) \<Blood, biochemistry, B2-MG, neck, chest and abdomen CT plain + enhanced, questionnaire, once every three months\> 1. Zerbutini