Previously untreated patients with follicular lymphoma are treated with the ZGCVP regimen (zanubrutinib, obinutuzumab, cyclophosphamide, vindesine, prednisolone) for 6 cycles.
Participate in the clinical study voluntarily, fully understand and be informed of the study, sign the informed consent in person, willing to follow and be able to complete all test procedures.
18-80 years old (inclusive), all genders.
Histopathologically confirmed grade 1-3a follicular lymphoma (FL) at stage III/IV or extensive stage II disease not suitable for radiotherapy, with at least one evaluable lesion (short axis ≥ 1.5 cm), meeting treatment indications according to GELF criteria or having a strong treatment desire.
No prior anti-tumor therapy, such as chemotherapy, radiotherapy, immunotherapy or biotherapy (tumor vaccine, cytokine, or growth factor controlling cancer).
Central nervous system involvement secondary to lymphoma.
Known severe allergic reactions to humanized or murine monoclonal antibodies, or known contraindications to any drug in the regimen.
History of other active malignant diseases within 2 years prior to study entry, but eligibility for inclusion: a) adequately treated carcinoma in situ of the cervix; b) local basal cell carcinoma or squamous cell carcinoma of skin; c) Pre-existing malignant disease that is under control and has undergone local radical treatment (surgical or other forms).
History of Human Immunodeficiency Virus (HIV) infection and/or other acquired Immunodeficiency syndrome. During screening period, patients with hepatitis B virus (HBV) surface antigen or hepatitis C virus (HCV) antibody positive must further test HBV DNA (no more than 2000 iu/ml) and HCV RNA (not exceed the method detection limit). Those ruling out active HBV or HCV infection are permitted to participate in the study. Carriers of the HBV, those with stable HBV after treatment or cured of HCV are also allowed to be enrolled.
Single group
ZGCVP
DrugPatients receive the ZGCVP regimen (zanubrutinib, obinutuzumab, cyclophosphamide, vindesine, prednisolone) for 6 cycles at the following dose: 1. Zanubrutinib: 160mg orally twice daily; 2. Obinutuzumab: 1000mg intravenously on days 1, 8, and 15 of cycle 1 and on day 1 of subsequent 5 cycles; 3. Cyclophosphamide: 750m/m2 intravenously on days 1 of every cycle; 4. Vindesine: 3 mg/m2 (maximum dose 4 mg) intravenously on days 1 of every cycle; 5. Prednisolone: 30mg orally three times daily on day 1-5 of every cycle. Patients achieving CR at stage II underwent observation directly; those at stage III/IV receive obinutuzumab maintenance every 8 weeks for 2 years (1000mg intravenously) until disease progression or withdrawal. Patients with disease progression during treatment switch to second-line therapy.
CRR
Complete response rate
ORR
Objective response rate
DOR
Duration of response
PFS
Progression free survival
OS
Overall survival
AE and SAE
Adverse event and serious adverse event
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