RecruitingPhase 2NCT06959732

Zanubrutinib Combined With G-CVP in Previously Untreated FL

Efficacy and Safety of Zanubrutinib Combined With G-CVP Regimen in Previously Untreated Follicular Lymphoma


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

40 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug combination for people with a type of slow-growing blood cancer called follicular lymphoma (FL) who have never been treated before. The combination includes zanubrutinib (a targeted pill) plus a standard chemotherapy regimen called G-CVP. The goal is to see if adding zanubrutinib makes the treatment more effective. **You may be eligible if...** - You are between 18 and 80 years old - You have been newly diagnosed with follicular lymphoma (grades 1, 2, or 3a) confirmed by a biopsy - You have not yet received any treatment for lymphoma - Your lymphoma is causing symptoms or other problems that need treatment - You are generally in good health and able to carry out daily activities - Your doctor expects you to live more than 2 years **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have significant liver, kidney, or blood count problems (unrelated to the lymphoma) - You have had a blood clot (deep vein thrombosis or pulmonary embolism) in the past year - You have another active cancer - You have a serious ongoing infection - You take medications that strongly interact with certain liver enzymes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGzanubrutinib, obinutuzumab,combined with CVP

Zanubrutinib (160 mg, twice daily \[bid\]), obinutuzumab (1000 mg on cycle 1 \[C1\], days 1, 8, and 15; on cycle 2 - 6 \[C 2-6\], day 1), cyclophosphamide (750 mg/㎡ on day 1), vincristine (1.4 mg/㎡, maximum dose 2 mg on day 1), and prednisone tablets (40 mg/㎡ once daily \[qd\] orally on days 1-5) were used every 21 days as a treatment cycle. Six cycles of treatment were completed, and the efficacy was reviewed every two cycles. Patients with PD were excluded from the group. MRD was detected after six cycles. If MRD was negative, routine maintenance therapy was performed (obinutuzumab 1000 mg once every 8 weeks, a total of 12 times). If MRD was positive, Zanubrutinib (160 mg, continuous bid) was added to the conventional maintenance therapy for 12 months.


Locations(1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT06959732


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