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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rocbrutinib | Experimental |
| |
| BR/R2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocbrutinib | Drug | 200mg qd PO. The treatment will continue until progressive disease, unacceptable toxicity, etc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | To assess the anti-tumor activity of Rocbrutinib and BR/R2 based on overall response rate (ORR) as assessed by Independent Reading Committee (IRC). | Up to 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | To assess the anti-tumor activity of Rocbrutinib and BR/R2 based on overall response rate (ORR) as assessed by investigator. | Up to 24 Months |
| Complete remission rate | To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 based on complete remission rate (CR) as assessed by investigator and IRC. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuankai Shi | Contact | 86+010-87788293 | syuankaipumc@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Cancer Hospital (West Branch of Anhui Provincial Hospital) | Not yet recruiting | Hefei | Anhui | China |
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| Bendamustine | Drug | 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 | Drug | 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 | Drug | 20mg qd PO day 1-21 |
|
| Up to 24 Months |
| Progression Free Survival | To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 based on Progression Free Survival (PFS) as assessed by investigator and IRC. | Up to 24 months |
| Overall survival | To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 based on Overall survival (OS) as assessed by investigator and IRC. | Measured from the date of date of first dose to the date of death or last visit, and for up to 5 years after the last subject is enrolled. |
| Duration of Response (DOR) | To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 based on Duration of response (DOR) as assessed by the Investigator and IRC. | Up to 24 months |
| Time to Response (TTR) | To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 based on Time to response (TTR) as assessed by the Investigator and IRC. | Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months. |
| Safety Assessment | To evaluate the safety of Rocbrutinib and BR/R2 by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0 | From first dose of study drug to 28 days after last dose of study drug |
| Beijing Shijitan Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
|
| Beijing Tongren Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
|
| National Cancer Center/Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | China |
|
| Peking University Third Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
|
| The First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | China |
|
| Fujian Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | China |
|
| Affiliated Cancer Hospital of Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | China |
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| Guangdong Provincial People's Hospital | Not yet recruiting | Guangzhou | Guangdong | China |
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| Nanfang Hospital | Not yet recruiting | Guangzhou | Guangdong | China |
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| Meizhou People's Hospital | Not yet recruiting | Meizhou | Guangdong | China |
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| Affiliated Tumor Hospital of Guangxi Medical University | Not yet recruiting | Nanning | Guangxi | China |
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| The First Affiliated Hospital of Guangxi Medical University | Not yet recruiting | Nanning | Guangxi | China |
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| The Fourth Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | China |
|
| The First Affiliated Hospital of Henan University of Science and Technology | Not yet recruiting | Luoyang | Henan | China |
|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | China |
|
| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | China |
|
| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | China |
|
| Hubei Cancer Hospital | Not yet recruiting | Wuhan | Hubei | China |
|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | China |
|
| The First Affiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | Hujian | China |
|
| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | China |
|
| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | China |
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| Jiangsu Cancer Hospital | Not yet recruiting | Nanjing | Jiangsu | China |
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| The First Affiliated Hospital of Soochow University | Not yet recruiting | Suzhou | Jiangsu | China |
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| The Affiliated Hospital of Xuzhou Medical University | Not yet recruiting | Xuzhou | Jiangsu | China |
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| Jiangxi Cancer Hospital | Not yet recruiting | Nanchang | Jiangxi | China |
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| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | China |
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| The First Hospital of Jilin University | Not yet recruiting | Jilin City | Jilin | China |
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| The Second Affiliated Hospital of Dalian Medical University | Not yet recruiting | Dalian | Liaoning | China |
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| Liaoning Cancer Hospital | Not yet recruiting | Shenyang | Liaoning | China |
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| Shengjing Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | China |
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| Linyi Cancer Hospital | Not yet recruiting | Linyi | Shandong | China |
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| Fudan University Shanghai Cancer Center | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| Shanxi Bethune Hospital | Not yet recruiting | Taiyuan | Shanxi | China |
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| Shanxi Province Cancer Hospital | Not yet recruiting | Taiyuan | Shanxi | China |
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| Sichuan Cancer Hospital | Not yet recruiting | Chengdu | Sichuan | China |
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| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | Tianjin | Tianjin Municipality | China |
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| The First Affiliated Hospital, Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | China |
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| The Second Affiliated Hospital of Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | China |
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| Zhejiang Cancer Hospital | Not yet recruiting | Hangzhou | Zhejiang | China |
|
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| D000069283 | Rituximab |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D054833 | Isoindoles |
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