Actively Recruiting
A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL
Led by InnoCare Pharma Inc. · Updated on 2024-12-27
476
Participants Needed
39
Research Sites
421 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)
CONDITIONS
Official Title
A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older, or age 60 to under 65 years if ineligible for or refusing stem cell transplant
- No prior systemic treatments for mantle cell lymphoma
- Mantle cell lymphoma confirmed by tissue tests including Cyclin D1 expression or t(11;14) translocation
- Modified Ann Arbor stage II to IV, with stage II patients requiring systemic treatment
- At least one measurable disease site with lymph node >1.5 cm or extranodal lesion >1.0 cm
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
You will not qualify if you...
- History of other cancers within 2 years before screening without recurrence or spread
- Gastrointestinal problems affecting drug intake or absorption, or history of total gastrectomy
- Treatment aimed at tumor reduction before stem cell transplant
- Use of strong cytochrome P450 3A inhibitors or inducers within 14 days before treatment or planned use during study
- Known central nervous system lymphoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 39 locations
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
2
Peking University Third Hospital
Beijing, China
Actively Recruiting
3
The First Affiliated Hospital of Bengbu Medical University
Bengbu, China
Actively Recruiting
4
First Hospital of Jilin University
Changchun, China
Not Yet Recruiting
5
Hunan Cancer Hospital
Changsha, China
Actively Recruiting
6
The First People's Hospital of Changzhou
Changzhou, China
Not Yet Recruiting
7
Sichuan Provincial People's Hospital
Chengdu, China
Actively Recruiting
8
West China Hospital of Sichuan University
Chengdu, China
Not Yet Recruiting
9
Chongqinq Cancer Hospital
Chongqing, China
Actively Recruiting
10
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Not Yet Recruiting
11
The second Hospital of Dalian Medical University
Dalian, China
Not Yet Recruiting
12
Fujing Cancer Hospital
Fuzhou, China
Actively Recruiting
13
Union Hospital Affiliated to Fujian Medical University
Fuzhou, China
Not Yet Recruiting
14
Guangdong Provincial People's Hospital
Guangzhou, China
Actively Recruiting
15
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
16
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Not Yet Recruiting
17
Zhejiang University Medical School affiliated to the first Hospital
Hangzhou, China
Actively Recruiting
18
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Actively Recruiting
19
Cancer Hospital of Shandong First Medical University
Jinan, China
Not Yet Recruiting
20
Shandong Provincial Hospital
Jinan, China
Not Yet Recruiting
21
The First Affiliated Hospital of Ningbo University
Jinan, China
Actively Recruiting
22
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, China
Not Yet Recruiting
23
The First Affiliated Hospital of Nanchang University
Nanchang, China
Actively Recruiting
24
Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
Nanjing, China
Not Yet Recruiting
25
Cancer Hospital Affiliated to Fudan University
Shanghai, China
Not Yet Recruiting
26
Huashan Hospital of Fudan University
Shanghai, China
Actively Recruiting
27
Shengjing Hospital of China Medical University
Shenyang, China
Not Yet Recruiting
28
The First Affiliated Hospital of China Medical University
Shenyang, China
Actively Recruiting
29
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
Not Yet Recruiting
30
Shanxi Cancer Hospital
Taiyuan, China
Not Yet Recruiting
31
Tianjin Cancer Hospital
Tianjin, China
Actively Recruiting
32
The Tumor Hospital Affiliated to Xinjiang Medical University
Ürümqi, China
Actively Recruiting
33
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and
Wuhan, China
Actively Recruiting
34
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and
Wuhan, China
Not Yet Recruiting
35
The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital)
Xi'an, China
Not Yet Recruiting
36
The Second Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, China
Not Yet Recruiting
37
Yibin Second People's Hospital
Yibin, China
Not Yet Recruiting
38
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
39
Henan Provincial People's Hospital
Zhengzhou, China
Not Yet Recruiting
Research Team
A
Alexia Lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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