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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥ 18 years , either sex. 2. Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal). 3. previous cancer treatment that works throughout the body (like chemotherapy) 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Orelabrutinib

Orelabrutinib Tablets

DRUG

Rituximab

Rituximab Injection

DRUG

Lenalidomide

Lenalidomide Capsules

DRUG

Rituximab

Rituximab Injection

Locations (19)

The First Affiliated Hospital of Bengbu Medical College
Bengbu, Auhui, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Henan Provincial Peoples Hospital
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
The first Hospital of China Medical University
Shenyang, Liaoning, China
The Affiliated Hospital Of Qingdao University
Qingdao, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital)
Xi’an, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China