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Zanubrutinib Combined With G-CVP in Previously Untreated FL

NCT06959732 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-07

No results posted yet for this study

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.

Conditions

  • Follicular Lymphoma ( FL)

Interventions

DRUG

zanubrutinib, 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.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06959732 on ClinicalTrials.gov