A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Rocbrutinib: 200mg qd PO. The treatment will continue until progressive disease, unacceptable toxicity, etc.
Bendamustine: Participants will receive a total of 6 cycles (a cycle being 28 days) 90 mg/m2 Bendamustine (IV infusion) on Days 1 and 2 of Cycles 1-6.
Rituximab: Participants will receive a total of 6 cycles (a cycle being 28 days) of 375 mg/m2 Rituximab (IV infusion) on Day 1 of each cycle.
Lenalidomide: 20mg qd PO day 1-21
Study summary
This is an open-label, randomized controlled, multicenter Phase II clinical study primarily evaluating the efficacy and safety of Rocbrutinib monotherapy compared to the investigator's choice of BR/R2 regimen in patients with non-GCB DLBCL.
Eligibility
Primary outcome measure(s)
- Overall Response Rate — Up to 24 Months
To assess the anti-tumor activity of Rocbrutinib and BR/R2 based on overall response rate (ORR) as assessed by Independent Reading Committee (IRC).
Trial sites (41)
| Facility | City | Region | Status |
|---|---|---|---|
| Anhui Cancer Hospital (West Branch of Anhui Provincial Hospital) | Hefei | Anhui | Not Yet Recruiting |
| Beijing Shijitan Hospital | Beijing | Beijing Municipality | Not Yet Recruiting |
| Beijing Tongren Hospital | Beijing | Beijing Municipality | Not Yet Recruiting |
| National Cancer Center/Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | Recruiting |
| Peking University Third Hospital | Beijing | Beijing Municipality | Not Yet Recruiting |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | Not Yet Recruiting |
| Fujian Cancer Hospital | Fuzhou | Fujian | Not Yet Recruiting |
| Affiliated Cancer Hospital of Guangzhou Medical University | Guangzhou | Guangdong | Not Yet Recruiting |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | Not Yet Recruiting |
| Nanfang Hospital | Guangzhou | Guangdong | Not Yet Recruiting |
| Meizhou People's Hospital | Meizhou | Guangdong | Not Yet Recruiting |
| Affiliated Tumor Hospital of Guangxi Medical University | Nanning | Guangxi | Not Yet Recruiting |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | Not Yet Recruiting |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | Not Yet Recruiting |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | Not Yet Recruiting |
| Henan Cancer Hospital | Zhengzhou | Henan | Recruiting |
| Henan Provincial People's Hospital | Zhengzhou | Henan | Not Yet Recruiting |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | Not Yet Recruiting |
| Hubei Cancer Hospital | Wuhan | Hubei | Not Yet Recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Not Yet Recruiting |
| The First Affiliated Hospital of Xiamen University | Xiamen | Hujian | Not Yet Recruiting |
| Hunan Cancer Hospital | Changsha | Hunan | Not Yet Recruiting |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | Not Yet Recruiting |
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | Not Yet Recruiting |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | Not Yet Recruiting |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | Not Yet Recruiting |
| Jiangxi Cancer Hospital | Nanchang | Jiangxi | Not Yet Recruiting |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | Not Yet Recruiting |
| The First Hospital of Jilin University | Jilin City | Jilin | Not Yet Recruiting |
| The Second Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | Not Yet Recruiting |
| Liaoning Cancer Hospital | Shenyang | Liaoning | Not Yet Recruiting |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | Not Yet Recruiting |
| Linyi Cancer Hospital | Linyi | Shandong | Not Yet Recruiting |
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | Not Yet Recruiting |
| Shanxi Bethune Hospital | Taiyuan | Shanxi | Not Yet Recruiting |
| Shanxi Province Cancer Hospital | Taiyuan | Shanxi | Not Yet Recruiting |
| Sichuan Cancer Hospital | Chengdu | Sichuan | Not Yet Recruiting |
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | Not Yet Recruiting |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | Not Yet Recruiting |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | Not Yet Recruiting |
+ 1 more sites — see the full list on the official registry below.
More Guangzhou Lupeng Pharmaceutical Company LTD. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07189065 on ClinicalTrials.gov ↗ ← All trials in China