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Clinical Trials in China / NCT06082102
Recruiting Phase 3

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

NCT06082102 · tracked via the Priya Life Science China tracker
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Phase
Phase 3
Started
2023-12-19
Last updated
2025-09-15

Condition(s) studied

Relapsed/Refractory Marginal Zone Lymphoma

Investigational drug(s) / intervention(s)

OrelabrutinibRituximabLenalidomideRituximab

Orelabrutinib: Orelabrutinib Tablets

Rituximab: Rituximab Injection

Lenalidomide: Lenalidomide Capsules

Rituximab: Rituximab Injection

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years , either sex. 2. Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal). 3. 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 4. Relapsed or refractory disease. 5. At least 1 measurable lesion confirmed through enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI). 6. ECOG performance status (PS) score of 0-2. Exclusion Criteria: 1. Administration of the specified anti-tumor therapies within 2 weeks prior to the first dose of the study treatment. 2. Administration of any other investigational product within 4 weeks prior to the first dose of the study treatment, or concurrent participation in another clinical trial.(Excluding patients who have discontinued treatment and are in long-term follow-up). 3. Prior treatment with any types of BTK inhibitor. 4. Patients refractory to lenalidomide plus rituximab (R2 regimen). Refractoriness is defined as either: Failure to achieve at least partial response (PR) after completing an adequate R2 treatment course (≥2 cycles at standard doses), OR Disease progression during R2 therapy or within 6 months after the last dose. 5. Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal involvements.

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical College Bengbu Auhui Recruiting
Beijing Tiantan Hospital, Capital Medical University Beijing Beijing Municipality Recruiting
Beijing Tongren Hospital, Capital Medical University Beijing Beijing Municipality Recruiting
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
Guangdong Provincial Hospital of Chinese Medicine Guangzhou Guangdong Recruiting
Henan Cancer Hospital Zhengzhou Henan Recruiting
Henan Provincial Peoples Hospital Zhengzhou Henan Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei Recruiting
Hunan Cancer Hospital Changsha Hunan Not Yet Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Recruiting
Jiangxi Cancer Hospital Nanchang Jiangxi Recruiting
The Second Hospital of Dalian Medical University Dalian Liaoning Recruiting
The first Hospital of China Medical University Shenyang Liaoning Recruiting
The Affiliated Hospital Of Qingdao University Qingdao Shandong Not Yet Recruiting
Yantai Yuhuangding Hospital Yantai Shandong Recruiting
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital) Xi’an Shanxi Recruiting
West China Hospital, Sichuan University Chengdu Sichuan Not Yet Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting

On this site

📄 Rituxan (rituximab) drug profile → 📄 Revlimid (lenalidomide) drug profile →

More Beijing InnoCare Pharma Tech Co., Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06082102 on ClinicalTrials.gov ↗ ← All trials in China