Efficacy and Safety of Orelabrutinib Plus Lenalidomide and Rituximab (R2) Compared to Placebo Plus R2 in r/r Marginal Zone Lymphoma
- Conditions
- Relapsed/Refractory Marginal Zone Lymphoma
- Interventions
- Registration Number
- NCT06082102
- Lead Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Brief Summary
Evaluate the Efficacy and Safety of Orelabrutinib Plus Lenalidomide and Rituximab (R2) Versus Placebo Plus R2 in Relapsed/Refractory Marginal Zone Lymphoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 324
- Age ≥ 18 years and ≤ 80 years, either sex.
- Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).
- At least one and no more than 3 prior lines of systemic therapy (CD20 targeted therapy included in at least one line).
- 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.
- Administration of the specified anti-tumor therapies within 2 weeks prior to the first dose of the study treatment.
- 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.
- Prior treatment with any types of BTK inhibitor.
- Prior allogeneic hematopoietic stem cell transplantation (Allo-HSCT), or Autologous hematopoietic stem cell transplantation (ASCT) within 6 months prior to the first dose of the study treatment; or prior CAR-T cell therapy.
- Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal involvements.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Orelabrutinib Placebo - Orelabrutinib Orelabrutinib - Orelabrutinib Lenalidomide - Placebo Lenalidomide - Orelabrutinib Rituximab - Placebo Rituximab -
- Primary Outcome Measures
Name Time Method IRC-assessed PFS Through study completion, an average of 5 year.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Auhui, China
Beijing Tongren Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Henan Provincial Peoples Hospital
🇨🇳Zhengzhou, Henan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, 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
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
Beijing Tiantan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Huashan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Guangdong Provincial Hospital of Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Anqing Municipal Hospital
🇨🇳Anqing, Auhui, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, Shandong, China