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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• Patients must meet all of the following criteria to be eligible:

• 1\. 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.

Locations
Other Locations
China
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Zhitao Ying
yingzhitao001@163.com
008613811818096
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 40
Treatments
Experimental: ZG- CVP
Zanubrutinib , obinutuzumab , cyclophosphamide , vincristine, and prednisone tablets 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 progressive disease (PD) were excluded from the group. MRD was detected after six cycles. If MRD was negative, routine maintenance therapy was performed . If MRD was positive, Zanubrutinib was added to the conventional maintenance therapy for 12 months.
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

This content was sourced from clinicaltrials.gov