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Clinical study of zanubrutinib combined with G-CHOP regimen in the treatment of newly diagnosed follicular lymphoma

Clinical study of zanubrutinib combined with G-CHOP regimen in the treatment of newly diagnosed follicular lymphoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098803
Enrollment
Unknown
Registered
2025-03-13
Start date
2025-03-20
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Follicular lymphoma

Interventions

ZG—CHOP treatment group:Patients were treated with zanubrutinib combined with the G-CHOP regimen (zanubrutinib:160mg, po bid, d1-d21
obinutuzumab: 1000 mg, iv, d1, d7, d14 for first cycle, d1 for other cycles
cyclophosphamide: 750mg/m^2, iv, d1
doxorubicin:50 mg/m^2, iv, d1
vincristine: 1.4mg/m^2 (maximum 2mg), iv, d1
and prednisone: 100mg, po, d1-5), administered every 3 weeks for a total of 6 cycles. Patients who completed the treatment course and achieved remission would enter the maintenance treatment phase, re

Sponsors

The Fourth Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients fully understand this study, voluntarily participate in and sign the informed consent form; 2. Age is >=18, =2 points); 5. No prior treatment for follicular lymphoma, including chemotherapy, immunotherapy, targeted therapy, local radiotherapy for lymphoma (except for local radiotherapy for alleviating tumor-related symptoms); 6. According to the 2014 lugano evaluation criteria for lymphoma, at least one CT/MRI measurable lesion (lymph node length > 1.5cm, extranodal lesion length diameter >1.0cm); 7. The function of major organs meets the following criteria: absolute neutrophil value >=1.0×10^9/L, platelet count >=75×10^9/L, hemoglobin >=80g/L, serum creatinine =50ml/min, left ventricular ejection fraction (LVEF) >=50%; 8. Expected survival >=3 months; 9. For males or females of childbearing potential who have not undergone sterilization surgery, agreement to use effective contraception during treatment and for 12 months after the last dose of study drug.

Exclusion criteria

Exclusion criteria: 1.Patients with follicular lymphoma transforming to diffuse large B-cell lymphoma; 2.Patients with tumor central nervous system infiltration; 3.Patients who are unable to swallow the capsule or have a medical condition that significantly affects gastrointestinal function, or who have a history of allergy to similar drugs and excipients of the investigational drug; 4.Patient has other active malignancies and other hematological diseases that require concurrent treatment; 5.Patients have an uncontrolled, active systemic fungal, bacterial, viral, or other infection; 6.Patients with significant and uncontrolled cardiovascular disease; 7.Patients with uncontrolled HBV or HCV infection (HBV surface antigen positive and/or HBV core antibody positive with more than 1×10^3 copies /mL of HBV DNA; More than 1×10^3 copies of HCV RNA /mL); 8.Patients with any life-threatening disease, medical condition, or organ system dysfunction that the investigator believes may affect the safety of the subject or pose a risk to the study.

Design outcomes

Primary

MeasureTime frame
ORR;CR;

Secondary

MeasureTime frame
Safety;

Countries

China

Contacts

Public ContactHaisheng Liu

The Fourth Hospital of Hebei Medical University

liuhs78299@163.com+86 139 3307 8299

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026