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NOT YET RECRUITING
NCT06918015
PHASE2

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

Sponsor: Zhejiang Cancer Hospital

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

58

Start Date

2025-05-01

Completion Date

2030-05-01

Last Updated

2025-04-15

Healthy Volunteers

No

Interventions

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.

Locations (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China