Actively Recruiting
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine Vs. Bendamustine and Rituximab in Treatment-Naive Mantle Cell Lymphoma
Led by InnoCare Pharma Inc. · Updated on 2024-12-27
476
Participants Needed
39
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of adding Orelabrutinib to a standard treatment of bendamustine plus rituximab in patients who have not previously been treated for mantle cell lymphoma (MCL). This phase 3, randomized, double-blind study aims to compare the combination of Orelabrutinib with bendamustine and rituximab versus bendamustine and rituximab alone. The study is sponsored by InnoCare Pharma Inc. and focuses on patients with treatment-naive MCL, typically older adults. Participants will be randomly assigned to one of two groups: one receiving Orelabrutinib orally along with bendamustine and rituximab injections, and the other receiving a placebo oral treatment with bendamustine and rituximab injections. Treatment will continue until the disease progresses or other reasons require stopping. The study uses a quadruple masking design, ensuring that participants and researchers do not know who is receiving Orelabrutinib or placebo. Throughout the study, participants will be monitored for dose-limiting toxicity within the first 28 days and followed for progression-free survival over approximately seven years. Researchers will conduct assessments to track disease status, side effects, and overall health. The trial involves regular visits, laboratory tests, and imaging to evaluate treatment effects and safety. Participants' involvement may last several years, including long-term follow-up to understand treatment outcomes and risks.
CONDITIONS
Brief 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 or older, or age 60 to under 65 if ineligible for or refusing stem cell transplant
- No prior systemic therapy for mantle cell lymphoma
- Modified Ann Arbor stage II-IV; stage II patients require systemic treatment
- Confirmed mantle cell lymphoma with Cyclin D1 expression and/or t (11; 14) chromosomal translocation
- At least one measurable disease site (lymph node > 1.5 cm or extranodal lesion > 1.0 cm)
- ECOG performance status of 0 to 2
You will not qualify if you...
- History of other malignant tumors with no recurrence or metastasis within 2 years before screening
- Gastrointestinal dysfunction affecting drug intake or total gastrectomy
- Therapy aimed at tumor debulking before stem cell transplant
- Use or planned use of strong cytochrome P450 3A inhibitors or inducers within 14 days or 5 half-lives before first study dose
- Known central nervous system lymphoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until disease progression or discontinuation
Participants receive Orelabrutinib or placebo orally, combined with Bendamustine and Rituximab by injection, until disease progression or other reasons for treatment discontinuation.
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
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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