Tests zanubrutinib with chemotherapy in untreated follicular lymphoma
Tests zanubrutinib with obinutuzumab and CVP in adults with follicular lymphoma.
Plain-language title generated from the registry record
Registry title: Zanubrutinib Combined With G-CVP in Previously Untreated FL
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06959732, who can take part
Where in China
- Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Trial code
- NCT06959732
- Record updated
- 7 May 2025
- Original description
The goal of this clinical trial is to learn the efficacy and safety of zanubrutinib in combination with G-CVP in previously untreated follicular lymphoma patients The main questions it aims to answer are: (1) Efficacy and safety of patients receiving zanubrutinib, obinutuzumab combined with cyclophosphamide, vincristine, and prednisone (CVP) regimen. (2) The difference in efficacy of patients with different minimal residual disease (MRD) status after treatment.Read full original descriptionShow less
Efficacy and Safety of Zanubrutinib Combined With G-CVP Regimen in Previously Untreated Follicular Lymphoma
The goal of this clinical trial is to learn the efficacy and safety of zanubrutinib in combination with G-CVP in previously untreated follicular lymphoma patients The main questions it aims to answer are: (1) Efficacy and safety of patients receiving zanubrutinib, obinutuzumab combined with cyclophosphamide, vincristine, and prednisone (CVP) regimen. (2) The difference in efficacy of patients with different minimal residual disease (MRD) status after treatment.
Participants will receive zanubrutinib combined with G-CVP, maintenance therapy will be determined by the MRD status after treatment.
Inclusion: Patients must meet all of the following criteria to be eligible:; 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: Severe concurrent infections; History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months; Known hypersensitivity to any component of the study drug; Drug abuse, medical, psychological, or social conditions that may interfere with study participation or result evaluation; 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); 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); 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; Patients will be excluded if they meet any of the following criteria:; Pregnant or breastfeeding women; Long-term use of strong or moderate CYP3A inducers; Investigator-deemed ineligibility for the study.