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NOT YET RECRUITING
NCT06474481
PHASE2

Zanubrutinib and G-CHOP in Untreated Intermediate-high Risk Follicular Lymphoma

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

:This is a an open-label, single-arm study to evaluate the efficacy and safety of zanubrutinib and G-CHOP in untreated Intermediate-high risk Follicular Lymphoma patients.

Official title: A Study of the Zanubrutinib With G-CHOP Regimens in the Frontline Treatment of Intermediate-high Risk Follicular Lymphoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-07

Completion Date

2029-12

Last Updated

2024-06-25

Healthy Volunteers

No

Conditions

Interventions

DRUG

Zanubrutinib

Zanubrutinib, 160mg PO BID.on days 1-28 Induction treatment: 4-6cycles ; Maintenance: 1 year;

DRUG

Obinutuzumab

Induction treatment: Obinutuzumab (G), 1000mg, IV, D1/8/15 (C1), D1 (C2-4/6); for 4-6 cycles, 1 cycle = 28 days Maintenance: Obinutuzumab (G), 1000mg, IV, every 2 months for 1 year;

DRUG

Prednisone

Prednisone (P), 100 mg, PO, D2-6;for 4-6 cycles for CHOP treatment , 1 cycle = 28 days

DRUG

Cyclophosphamide

Cyclophosphamide (C), 750 mg/m2, IV, D2; for 4-6 cycles for CHOP treatment , 1 cycle = 28 days

DRUG

Vincristine

Vincristine (O), 1.4 mg/m2 (maximum 2 mg), IV, D2; for 4-6 cycles for CHOP treatment , 1 cycle = 28 days

DRUG

Doxorubicin

Doxorubicin (H), 50 mg/m2, IV, D2; for 4-6 cycles for CHOP treatment ,1 cycle = 28 days