NCT06918015

Zanubrutinib Plus GCVP (Obinutuzumab, Cyclophosphamide, Vindesine, Prednisolone) in Previously Untreated Follicular Lymphoma

A Prospective, Single-arm, Phase II Study of Zanubrutinib in Combination With GCVP (Obinutuzumab, Cyclophosphamide, Vindesine, Prednisolone) in Previously Untreated Follicular Lymphoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Previously untreated patients with follicular lymphoma are treated with the ZGCVP regimen (zanubrutinib, obinutuzumab, cyclophosphamide, vindesine, prednisolone) for 6 cycles.

Detailed description

This is a prospective, single-arm, multi-center, phase II clinical study aiming at evaluating the efficacy and safety of zanubrutinib with GCVP (obinutuzumab, cyclophosphamide, vindesine, prednisolone) in untreated follicular lymphoma (FL). It includes screening (14 days before the first dose), treatment, and follow-up phases. Screening: Recruitment subjects are grade 1-3a, stage III/IV or extensive stage II (unsuitable for radiotherapy) FL patients, with measurable lesions (short axis ≥1.5cm), meeting GELF criteria or having strong treatment desire. Treatment: Patients receive the ZGCVP regimen for 6 cycles (21-day/cycle). Imaging evaluation was conducted at the end of every 2 cycles. Enhanced Computed Tomography (CT) and ultrasound are performed after 2 cycles of the ZGCVP regimen, while interim Positron Emission Tomography (iPET) is performed after 4/6 cycles. Bone marrow examination is required for those with initial bone marrow involvement after achieving Imaging complete response. Efficacy assessment indicators include complete response rate (CR), objection response rate (ORR), duration of response (DOR), progression free survival (PFS), overall survival (OS) and disease transformation rate according to Lugano 2014 criteria. Safety assessment indicators inlude adverse events basing on CTCAE 5.0. Follow-up: Patients achieving CR at stage II underwent observation directly; those at stage III/IV receive obinutuzumab maintenance every 8 weeks for 2 years until disease progression or withdrawal. Patients with disease progression during treatment switch to second-line therapy.

Conditions

• BTK Inhibitors
• Follicular Lymphoma
• Immunochemotherapy

Interventions

Type	Name	Description
DRUG	ZGCVP	Patients 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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2028-05-01
• Completion: 2030-05-01
• First posted: 2025-04-09
• Last updated: 2025-04-15

Locations

1 site across 1 country: China