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This is an open-label, single arm, multi-center Phase 2 study of oral Rocbrutinib in patients with mantle cell lymphoma who are failed or relapsed after remission or intolerated to Bruton's tyrosine kinase (BTK) inhibitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rocbrutinib | Experimental | Subjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocbrutinib | Drug | Subjects to take Rocbrutinib tablets orally with 240mL water, without food, Once daily.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 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 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 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 | Affiliation | Role |
|---|---|---|
| Jun Zhu, MD, PhD | Peking University Cancer Hospital & Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui provincial cancer hospital | Hefei | Anhui | China | |||
| The first affiliated hospital of Anhui medical university |
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|
| Up to 24 Months |
| Progression Free Survival | To assess the preliminary anti-tumor activity of Rocbrutinib based on Progression Free Survival (PFS) as assessed by investigator and IRC. | Measured from the date of first dose of study drug to the date of earliest disease progression or death or last visit, and assessed up to 24 months. |
| Overall survival | To assess the preliminary anti-tumor activity of Rocbrutinib 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 based on Duration of response (DOR) as assessed by the Investigator and IRC. | Measured from the date of the first remission to the date of earliest disease progression or death, and assessed up to 24 months. |
| Time to Response (TTR) | To assess the preliminary anti-tumor activity of Rocbrutinib 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 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 |
| Maximum Observed Plasma Concentration (Cmax) | Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of Rocbrutinib | Up to 24 hours post dose |
| Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t) | PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t) of Rocbrutinib | Up to 24 hours post dose |
| Maximum Observed Plasma Concentration (Tmax) | PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) Of Rocbrutinib | Up to 24 hours post dose |
| Half-life period (T1/2) | PK As Assessed By Time To Half-life period (T1/2) Of Rocbrutinib | Up to 24 hours post dose |
| Quality of life (QoL) | Quality of life Assessed By the European Organization for Research and Treatment of Cancer core quality of life (EORTC QLQ-C30) questionnaire (The total score ranges from 30 to126, Items 29 and 30 are scored from 1 to 7 points, and other items are scored from 1 to 4 points. Except for items 29 and 30, the higher value, the worse QoL.) | Up to 24 Months |
| Hefei |
| Anhui |
| China |
| Peking University Third Hospital | Beijing | Beijing Municipality | 100089 | China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| The first affiliated hospital of Chongqing mediacal university | Chongqing | Chongqing Municipality | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | China |
| Fujian Medical university union hospital | Fuzhou | Fujian | China |
| The first affiliated hospital of Xiamen university | Xiamen | Fujian | China |
| Gansu provincial cancer hospital | Lanzhou | Gansu | China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Meizhou people'shospital | Meizhou | Guangdong | China |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | China |
| The fourth hospital of Hebei medical university | Shijiazhuang | Hebei | China |
| Harbin First Hospital | Harbin | Heilongjiang | China |
| The First Affiliated Hospital of Henan University of Science & Technology | Luoyang | Henan | China |
| Henan Cancer Hospital | Zhengzhou | Henan | China |
| Henan provincial people's hospital | Zhengzhou | Henan | China |
| The first affiliated hospital of Zhengzhou university | Zhengzhou | Henan | China |
| Hunan cancer hospital | Changsha | Hunan | China |
| Jiangsu cancer hospital | Nanjing | Jiangsu | China |
| Jiangsu province hospital | Nanjing | Jiangsu | China |
| The first affiliated hospital of Nanchang university | Nanchang | Jiangxi | China |
| The second hospital of dalian medical university | Dalian | Liaoning | China |
| Shengjing hospital of China medical university | Shenyang | Liaoning | China |
| The first hospital of China medical university | Shenyang | Liaoning | China |
| Qilu hospital of Shandong university | Jinan | Shandong | China |
| Shandong Cancer Hospital | Jinan | Shandong | China |
| West China School of Medicine | Chengdu | Sichuan | China |
| Tianjin Hematonosis Hospital | Tianjin | Tianjin Municipality | China |
| Tianjin medical university cancer hospital | Tianjin | Tianjin Municipality | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China |
| Affiliated hospital of hebei university | Baoding | China |
| Beijing Boren Hospital | Beijing | China |
| Beijing Friendship hospital | Beijing | China |
| The First Bethune Hospital of Jilin University | Changchun | China |
| Sichuan Cancer Hospital | Chengdu | China |
| The First People's Hospital of Foshan | Foshan | China |
| Nanfang Hospital, Southern Medical University | Guangzhou | China |
| Sun Yat-sen Memorial Hospital | Guangzhou | China |
| The First Affiliated Hospital of Soochow University | Suzhou | China |
| The first affiliated hospital of Wenzhou medical university | Wenzhou | China |
| Hubei Cancer Hospital | Wuhan | China |
| Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology | Wuhan | China |
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| 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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