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The purpose of this study is to assess the progression free survival (PFS) in the real-world settings of polatuzumab among Chinese diffuse large B cell lymphoma (DLBCL) participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Unfit/frail participants with DLBCL who are untreated before the administration of polatuzumab and who have started receiving polatuzumab at physician's discretion in accordance with local clinical practice and/or labeling will be observed for safety and efficacy until death, withdrawal of consent, loss to follow-up or end of study whichever occurs first (up to approximately 3 years). |
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| Cohort 2 | Participants with DLBCL who can not be classified into unfit/frail but are untreated before the administration of polatuzumab and who have started receiving polatuzumab at physician's discretion in accordance with local clinical practice and/or labeling will be observed for safety and efficacy until death, withdrawal of consent, loss to follow-up or end of study whichever occurs first (up to approximately 3 years). |
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| Cohort 3 | Participants with relapsed or refractory (R/R) DLBCL who have started receiving polatuzumab at physician's discretion in accordance with local clinical practice and/or labeling will be observed for safety and efficacy until death, withdrawal of consent, loss to follow-up or end of study whichever occurs first (up to approximately 3 years). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polatuzumab Vedotin | Drug | Polatuzumab vedotin will be administered at the discretion of the physician per local clinical practice and local labeling. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cohorts 1 and 2: Progression Free Survival at 24 months (PFS24) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | At 24 months | |
| Cohort 3: PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | Baseline up to end of study (EOS) (approximately 38 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 3: PFS24 Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | At 24 months | |
| Cohorts 1, 2 and 3: Time to Next Treatment (TTNT) | From the start of polatuzumab treatment to the initiation of next-line treatment (up to approximately 38 months) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who will be treated with polatuzumab (known as being recommended and having the intention to be treated with polatuzumab at the time of signing informed consent) or have initiated polatuzumab treatment within three months prior to enrollment and after the indication approval will be observed in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ML44616 https://forpatients.roche.com/ | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Active, not recruiting | Beijing | 100032 | China | ||
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Cohorts 1, 2 and 3: Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | Baseline up to EOS (approximately 38 months) |
| Cohorts 1, 2 and 3: Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | Baseline up to EOS (approximately 38 months) |
| Cohorts 1 and 2: Disease Control Rate (DCR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | Baseline up to EOS (approximately 38 months) |
| Cohorts 1, 2 and 3: Duration of Response (DoR) | From the date of the first occurrence of a documented CR or partial response (PR) to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 38 months) |
| Cohorts 1 and 2: Disease Free Survival (DFS) | From the date of the first occurrence of a documented CR, to the date of relapse or death from any cause, whichever occurs first (up to approximately 38 months) |
| Cohorts 1 and 2: Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | From the start of polatuzumab treatment to any treatment failure including disease progression, relapse, initiation of new antilymphoma therapy (NALT), or death from any cause, which occurs first (up to approximately 38 months) |
| Cohorts 1, 2 and 3: Overall Survival (OS) | From the start of polatuzumab treatment until the date of death from any cause (up to approximately 38 months) |
| Cohorts 1, 2 and 3: Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | AEs will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | Up to EOS (approximately 38 months) |
| Peking University Third Hospital |
| Recruiting |
| Beijing |
| 100191 |
| China |
| Beijing Hospital of Ministry of Health | Active, not recruiting | Beijing | 100730 | China |
| Beijing Tongren Hospital, Capital Medical University | Active, not recruiting | Beijing | 100730 | China |
| The First Bethune Hospital of Jilin University | Active, not recruiting | Changchun | China |
| Xiangya Hospital of Centre-South University | Active, not recruiting | Changsha | 410008 | China |
| Third Xiangya Hospital of Central South University | Recruiting | Changsha | China |
| Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital | Active, not recruiting | Chengdu | 610072 | China |
| Zhujiang Hospital, Southern Medical University | Active, not recruiting | Guangzhou | 510280 | China |
| Guizhou Cancer Hospital | Recruiting | Guiyang | 550004 | China |
| Hainan Cancer Hospital | Recruiting | Haikou | China |
| Affiliated Hospital of Inner Mongolia Medical University | Recruiting | Hohhot | 010000 | China |
| Jiangxi Cancer Hospital | Recruiting | Nanchang | 330029 | China |
| Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) | Active, not recruiting | Nanjing | 210029 | China |
| Jiangsu Cancer Hospital | Active, not recruiting | Nanjing | 211100 | China |
| The Affiliated Hospital Of Qingdao University | Recruiting | Qingdao | DUMMY_VALUE | China |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | 200025 | China |
| Tongji Hospital of Tongji University | Active, not recruiting | Shanghai | 200065 | China |
| China Medical University (CMU) First Affiliated Hospital | Recruiting | Shenyang | 110001 | China |
| The Fourth Hospital of Hebei Medical University | Active, not recruiting | Shijiazhuang | China |
| Shanxi Province Cancer Hospital | Active, not recruiting | Taiyuan | 030013 | China |
| Tianjin Medical University General Hospital | Recruiting | Tianjin | 300052 | China |
| Tianjin Cancer Hospital | Recruiting | Tianjin | 300060 | China |
| Xinjiang Medical University Cancer Hospital | Active, not recruiting | Ürümqi | 830011 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Active, not recruiting | Wuhan | 430022 | China |
| Wuxi People's Hospital | Recruiting | Wuxi | 214023 | China |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University | Active, not recruiting | Xi'an | 710061 | China |
| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | China |
| Henan Cancer Hospital | Recruiting | Zhengzhou | 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 |
|---|---|
| C000600736 | polatuzumab vedotin |
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