MedPath

Efficacy and Safety of Orelabrutinib Plus Lenalidomide and Rituximab (R2) Compared to Placebo Plus R2 in r/r Marginal Zone Lymphoma

Phase 3
Recruiting
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
Inclusion Criteria
  1. Age ≥ 18 years and ≤ 80 years, either sex.
  2. Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).
  3. At least one and no more than 3 prior lines of systemic therapy (CD20 targeted therapy included in at least one line).
  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.
Read More
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.
  3. Prior treatment with any types of BTK inhibitor.
  4. 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.
  5. Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal involvements.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboOrelabrutinib Placebo-
OrelabrutinibOrelabrutinib-
OrelabrutinibLenalidomide-
PlaceboLenalidomide-
OrelabrutinibRituximab-
PlaceboRituximab-
Primary Outcome Measures
NameTimeMethod
IRC-assessed PFSThrough study completion, an average of 5 year.
Secondary Outcome Measures
NameTimeMethod

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

© Copyright 2025. All Rights Reserved by MedPath