RecruitingPhase 2NCT07719556

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

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)


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

39 participants

Start Date

Jul 15, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Obinutuzumab, a drug called Orelabrutinib, and others for people with mantle cell lymphoma (mcl). The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOrelabrutinib

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

DRUGObinutuzumab

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)

DRUGVenetoclax

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

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NCT07719556


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