Trial Title:
Efficacy and Safety of Orelabrutinib Plus Lenalidomide and Rituximab (R2) Compared to Placebo Plus R2 in r/r Marginal Zone Lymphoma
NCT ID:
NCT06082102
Condition:
Relapsed/Refractory Marginal Zone Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Rituximab
Lenalidomide
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Orelabrutinib
Description:
Orelabrutinib Tablets
Arm group label:
Orelabrutinib
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Lenalidomide Capsules
Arm group label:
Orelabrutinib
Arm group label:
Placebo
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Rituximab Injection
Arm group label:
Orelabrutinib
Arm group label:
Placebo
Intervention type:
Drug
Intervention name:
Orelabrutinib Placebo
Description:
Orelabrutinib Placebo Tablets
Arm group label:
Placebo
Summary:
Evaluate the Efficacy and Safety of Orelabrutinib Plus Lenalidomide and Rituximab (R2)
Versus Placebo Plus R2 in Relapsed/Refractory Marginal Zone Lymphoma.
Criteria for eligibility:
Criteria:
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.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anqing Municipal Hospital
Address:
City:
Anqing
Zip:
246003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Fusheng Yao
Facility:
Name:
The First Affiliated Hospital of Bengbu Medical College
Address:
City:
Bengbu
Zip:
233000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yanli Yang
Facility:
Name:
Beijing Tiantan Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
100070
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Lin Fu
Facility:
Name:
Beijing Tongren Hospital, Capital Medical University
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Liang Wang
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510055
Country:
China
Status:
Recruiting
Contact:
Last name:
Huiqiang Huang
Facility:
Name:
Guangdong Provincial Hospital of Chinese Medicine
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiping Dai
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Contact:
Last name:
Keshu Zhou
Facility:
Name:
Henan Provincial Peoples Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Contact:
Last name:
Zunmin Zhu
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Hu
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yajun Li
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Recruiting
Contact:
Last name:
Fei Li
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Zip:
330029
Country:
China
Status:
Recruiting
Contact:
Last name:
Wuping Li
Facility:
Name:
The Second Hospital of Dalian Medical University
Address:
City:
Dalian
Zip:
116023
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaojing Yan
Facility:
Name:
The first Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110002
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaojing Yan
Facility:
Name:
The Affiliated Hospital Of Qingdao University
Address:
City:
Qingdao
Zip:
266000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xia Zhao
Facility:
Name:
Yantai Yuhuangding Hospital
Address:
City:
Yantai
Zip:
264099
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoxia Chu
Facility:
Name:
Huashan Hospital, Fudan University
Address:
City:
Shanghai
Zip:
200040
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yan Yuan
Facility:
Name:
The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital）
Address:
City:
Xi'an
Zip:
710004
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wanhong Zhao
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Liqun Zou
Facility:
Name:
The First Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenjuan Yu
Start date:
December 19, 2023
Completion date:
February 25, 2030
Lead sponsor:
Agency:
Beijing InnoCare Pharma Tech Co., Ltd.
Agency class:
Industry
Source:
Beijing InnoCare Pharma Tech Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06082102
