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This is a study to evaluate the safety and efficacy of TQ-B3525 tablets in patients with relapsed / refractory mantle cell lymphoma (MCL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ-B3525 tablet | Experimental | TQ-B3525 tablet administered orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ-B3525 | Drug | TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) assessed by Independent Review Committee (IRC) | Percentage of subjects achieving complete response (CR) and partial response (PR) based on investigator. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate(DCR) | Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD). | up to 12 months |
| Duration of Response (DOR) | DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jifeng Feng | Contact | fjif@vip.sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Cancer Hospital | Not yet recruiting | Hefei | Anhui | China |
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| up to 12 months |
| Progression-free survival (PFS) | PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause. | up to 12 months |
| Overall survival (OS) | OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. | up to 18 months |
| Biomarkers | To assess the changes of genes related to PI3K pathway and bypass in the tissues and / or plasma of enrolled patients. | up to 12 months |
| The First Affiliated Hospital of Anhui Medical University | Not yet recruiting | Hefei | Anhui | China |
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| Beijing Boren Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Beijing Shijitan Hospital Affiliated to Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Cancer Hospital of Chinese Academy of Medical Sciences | Not yet recruiting | Beijing | Beijing Municipality | China |
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| The Fifth Medical Center of PLA General Hospital | Not yet recruiting | Beijing | Beijing Municipality | China |
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| The Third Hospital of Peking University | Not yet recruiting | Beijing | Beijing Municipality | China |
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| Fujian Cancer Hospital | Not yet recruiting | Fuzhou | Fujian | China |
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| Union Hospital Affiliated to Fujian Medical University | Not yet recruiting | Fuzhou | Fujian | China |
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| The First Affiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | Fujian | China |
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| The Second Hospital of Lanzhou University | Not yet recruiting | Lanzhou | Gansu | China |
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| Guangdong Provincial People's Hospital | Not yet recruiting | Guangzhou | Guangdong | China |
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| Sun Yat-sen University Cancer Center | Not yet recruiting | Guangzhou | Guangdong | China |
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| Guangxi Medical University Affiliated Tumor Hospital | Not yet recruiting | Nanning | Guangxi | China |
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| Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | China |
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| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | China |
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| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | China |
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| Huai'an first people's Hospital | Not yet recruiting | Huaian | Jiangsu | China |
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| Jiangsu Cancer Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| Nanjing Drum Tower Hospital | Not yet recruiting | Nanjing | Jiangsu | China |
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| Nantong Tumor Hospital | Not yet recruiting | Nantong | Jiangsu | China |
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| The First Affiliated Hospital of Suzhou University | Not yet recruiting | Suzhou | Jiangsu | China |
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| Jiangxi Cancer Hospital | Not yet recruiting | Nanchang | Jiangxi | China |
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| The First Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | China |
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| Affiliated Zhongshan Hospital of Dalian University | Not yet recruiting | Dalian | Liaoning | China |
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| The First Affiliated Hospital of Dalian Medical University | Not yet recruiting | Dalian | Liaoning | China |
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| The Second Affiliated Hospital of Dalian Medical University | Not yet recruiting | Dalian | Liaoning | China |
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| Affiliated Hospital of Binzhou Medical College | Recruiting | Binzhou | Shandong | China |
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| Qingdao Central Hospital | Not yet recruiting | Qingdao | Shandong | China |
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| Weifang People's Hospital | Recruiting | Weifang | Shandong | China |
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| Weihai Central Hospital | Not yet recruiting | Weihai | Shandong | China |
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| Weihai Municipal Hospital | Not yet recruiting | Weihai | Shandong | China |
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| Shanghai Tongji Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| Shanxi Provincial People's Hospital | Not yet recruiting | Xi’an | Shanxi | China |
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| Hematology Hospital of Chinese Academy of Medical Sciences | Not yet recruiting | Tianjin | Tianjin Municipality | China |
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| Tianjin Cancer Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | China |
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| Tianjin Medical University General Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | China |
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| Tianjing People's Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | China |
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| 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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| ID | Term |
|---|---|
| C000730996 | TQ-B3525 |
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