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RECRUITING
NCT07719556
PHASE2

Orelabrutinib Combined With Obinutuzumab and Short-Course Venetoclax in Patients With Treatment-Naïve Mantle Cell Lymphoma (MCL)

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

This study aims to evaluate the safety and efficacy of orelabrutinib (O) in combination with obinutuzumab (G) and short-course venetoclax (V) in patients with treatment-naïve MCL.

Official title: A Prospective, Multicenter, Open-label, Single-arm Phase II Clinical Study of Orelabrutinib in Combination With Obinutuzumab and Short-course Venetoclax in Patients With Treatment-naïve Mantle Cell Lymphoma (MCL)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2026-07-15

Completion Date

2029-07-01

Last Updated

2026-07-22

Healthy Volunteers

No

Interventions

DRUG

Orelabrutinib

Orelabrutinib: 150 mg, d1-d28, C1-C6 (Induction Phase ) ; 150 mg, d1-d28, C7-C24 (Maintenance Phase)

DRUG

Obinutuzumab

Obinutuzumab: 1000 mg/m², on d1, d8, and d15 in C1; and on d1 in C2-C6 (Induction Phase ) ; 1000 mg/m², d1, once every 2 cycles, C7-C24 (Maintenance Phase)

DRUG

Venetoclax

Venetoclax: dose ramp-up in C2 (20 mg → 400 mg); 400 mg on d1-d14 in C3-C6(Induction Phase ) ; 400 mg, d1-d14, C7-C24(Maintenance Phase)

Locations (2)

Changzhou Second People's Hospital

Changzhou, Jiangsu, China

Jiangsu province Hospital

Nanjing, Jiangsu, China