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NOT YET RECRUITING
NCT05918276
PHASE2

Clinical Study of Orelabrutinib Combined With BG Regimen First-line Treatment of CLL/SLL

Sponsor: Nanfang Hospital, Southern Medical University

View on ClinicalTrials.gov

Summary

This study aims to investigate the treatment of navie CLL/SLL with orelabrutinib, bendamustine and obinutuzumab . The primary endpoint is the rate of CR and uMRD, and the second endpoints are survival time (OS and PFS) and toxicities.

Official title: Exploratory Clinical Study of Orelabrutinib in Combination With BG Regimen in Patients With Naive and Unfit CLL/SLL Without 17p- or TP53 Mutations

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2023-07-15

Completion Date

2026-12-30

Last Updated

2023-06-26

Healthy Volunteers

No

Conditions

Interventions

DRUG

Orelabrutinib and BG

Drug: Orelabrutinib Orelabrutinib 200mg, po, qd,C2-C7. Twenty-eight days for a cycle. Drug: BG Bendamustin 70mg/m2, IV, d2\&d3 inC1, and then d1\&d2 inC2-6.Twenty-eight days for a cycle. Obintuzumab 100mg IV, d1, 900mg d2, 1000mg d8\&d15 in C1, and then 1000mg/m2 IV, d1 in C2-6. Twenty-eight days for a cycle.

Locations (2)

The Central Hospital Of Wuan

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China