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This is a phase 3, open-label, randomized, multinational study to evaluate the anti-tumor efficacy of golidocitinib versus investigator's choice in adult patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL). This study will treat patients with pathologically confirmed PTCL who have relapsed after or been refractory/intolerant to at least one prior systemic treatment regimen(s).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Golidocitinib | Experimental |
| |
| Investigator's Choice | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golidocitinib | Drug | 150 mg, orally, once daily, with or without food, in a 21-day cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) according to Lugano 2014 | The time from the date of randomization to the date of first progressive disease, death due to any cause whichever occurred first. Approximately 4 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | The time from randomization to death due to any cause. Approximately 4 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ling Zhou | Contact | 021-61095755 | ling.zhou@dizalpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhao | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Cancer Hospital | Recruiting | Hefei | Anhui | 230000 | China |
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| Chidamide |
| Drug |
30 mg, orally, twice a week, with an interval of no less than 3 days in a 21-day cycle |
|
| Gemcitabine | Drug | 1000 mg/m2, intravenous infusion, administered on Day 1, Day 8 and Day 15 of a 28-day cycle |
|
| The Second Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | 230601 | China |
|
| Beijing Hospital | Recruiting | Beijing | Beijing Municipality | 100005 | China |
|
| Beijing Tongren Hospital, CMU | Recruiting | Beijing | Beijing Municipality | 100051 | China |
|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
|
| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400016 | China |
|
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350011 | China |
|
| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | 361026 | China |
|
| The First Hospital of Lanzhou University | Recruiting | Lanzhou | Gansu | 730013 | China |
|
| Gansu Provincial Cancer Hospital | Recruiting | Lanzhou | Gansu | 730050 | China |
|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510210 | China |
|
| Guangxi Medical University Cancer Hospital | Recruiting | Nanning | Guangxi | 530200 | China |
|
| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | 150081 | China |
|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450008 | China |
|
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
|
| Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430048 | China |
|
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430071 | China |
|
| Hubei Cancer Hospital | Recruiting | Wuhan | Hubei | 430079 | China |
|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
|
| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210008 | China |
|
| The First Bethune Hospital of Jilin University | Recruiting | Changchun | Jilin | China |
|
| Shengjing Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110134 | China |
|
| Shandong Cancer Hospital & Institution | Recruiting | Jinan | Shandong | 250117 | China |
|
| Linyi Cancer Hospital | Recruiting | Linyi | Shandong | 276304 | China |
|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
|
| Tongji Hospital of Tongji University | Recruiting | Shanghai | Shanghai Municipality | 200065 | China |
|
| Shanxi Provincial Cancer Hospital | Recruiting | Taiyuan | Shanxi | 30013 | China |
|
| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi’an | Shanxi | 710061 | China |
|
| Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital | Recruiting | Chengdu | Sichuan | 610072 | China |
|
| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
|
| The First Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310006 | China |
|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
|
| Jinhua Municipal Centeral Hospital | Recruiting | Jinhua | Zhejiang | 321000 | China |
|
| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325015 | China |
|
| Chang Bing Show Chwan Memorial Hospital | Recruiting | Changhua | 00505 | Taiwan |
|
| Kaohsiung Chang Gung Memorial Hospital | Recruiting | Kaohsiung City | 00833 | Taiwan |
|
| Taipei Medical University - Shuang Ho Hospital | Recruiting | New Taipei City | 23561 | Taiwan |
|
| China Medical University Hospital | Recruiting | Taichung | 40447 | Taiwan |
|
| Chi Mei Medical Center - Liouying Branch | Recruiting | Tainan | 00736 | Taiwan |
|
| National Cheng Kung University Hospital | Recruiting | Tainan | 70403 | Taiwan |
|
| National Taiwan University Hospital | Recruiting | Taipei | 10048 | Taiwan |
|
| Koo Foundation Sun Yat-Sen Cancer Center | Recruiting | Taipei | 11259 | Taiwan |
|
| King Chulalongkorn Memorial Hospital | Recruiting | Bangkok | 10330 | Thailand |
|
| Mahidol University - Faculty of Medicine - Ramathibodi Hospital | Recruiting | Bangkok | 10400 | Thailand |
|
| Phramongkutklao Hospital | Recruiting | Bangkok | 10400 | Thailand |
|
| Siriraj Hospital - Mahidol University | Recruiting | Bangkok | 10700 | Thailand |
|
| Maharaj Nakorn Chiang Mai Hospital | Recruiting | Chiang Mai | 50200 | Thailand |
|
| Prince of Songkla University-Faculty of Medicine | Recruiting | Hat Yai | 90110 | Thailand |
|
| Srinagarind Hospital - Faculty of Medicine Khon Kaen University | Not yet recruiting | Khon Kaen | 40002 | Thailand |
|
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-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 |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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