A Randomized, Controlled, Open-label, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Orelabrutinib Plus Rituximab Versus Lenalidomide Plus Rituximab in Relapsed/Refractory Marginal Zone Lymphoma

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Efficacy and Safety of Orelabrutinib Combined with Rituximab versus Lenalidomide Combined with Rituximab in Patients with Relapsed/Refractory Marginal Zone Lymphoma

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years , either sex.

• Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).

• Prior systemic therapy including at least one anti-CD20 monoclonal antibody-containing regimen is required, with the following specifications:

• For combination therapies: Minimum of 2 completed treatment cycles For anti-CD20 monotherapy: Minimum of 4 administered doses Progression during treatment waives cycle/dose requirements

• Relapsed or refractory disease.

• At least 1 measurable lesion confirmed through enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI).

• ECOG performance status (PS) score of 0-2.

Locations
Other Locations
China
Beijing Tiantan Hospital, Capital Medical University
RECRUITING
Beijing
Beijing Tongren Hospital, Capital Medical University
RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical College
RECRUITING
Bengbu
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
West China Hospital, Sichuan University
NOT_YET_RECRUITING
Chengdu
The Second Hospital of Dalian Medical University
RECRUITING
Dalian
Guangdong Provincial Hospital of Chinese Medicine
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
The First Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Jiangxi Cancer Hospital
RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The Affiliated Hospital Of Qingdao University
NOT_YET_RECRUITING
Qingdao
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
The first Hospital of China Medical University
RECRUITING
Shenyang
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital)
RECRUITING
Xi’an
Yantai Yuhuangding Hospital
RECRUITING
Yantai
Henan Cancer Hospital
RECRUITING
Zhengzhou
Henan Provincial Peoples Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Alexia Lu
CO_HGRAC@innocarepharma.com
010-66609745
Time Frame
Start Date: 2023-12-19
Estimated Completion Date: 2030-02-25
Participants
Target number of participants: 324
Treatments
Experimental: Orelabrutinib
Active_comparator: Comparator
Related Therapeutic Areas
Sponsors
Leads: Beijing InnoCare Pharma Tech Co., Ltd.

This content was sourced from clinicaltrials.gov

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