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This study will investigate how well glofitamab-based therapy works and how safe it is in Chinese adult participants with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glofitamab treatment | Participants will be enrolled into the study either prior to initiation of glofitamab therapy or within 90 days of starting glofitamab therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glofitamab | Drug | Participants will receive glofitamab as part of a cancer-treatment regimen in a real-world setting. No intervention will be administered by study investigators. |
|
| Measure | Description | Time Frame |
|---|---|---|
| real-world Progression-Free Survival (rwPFS) | Up to approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate (CRR) | CRR is defined as the proportion of participants whose best overall response (BOR) is a complete response (CR) on positron emission tomography/computed tomography (PET/CT) or CT during the study assessed by the investigator according to 2014 Lugano Response Criteria for Malignant Lymphoma | Up to approximately 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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Adult Chinese participants with R/R DLBCL who will be treated with a glofitamab-based regimen either after enrollment into the study or within 90 days prior to enrollment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: ML45172 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. and Canada) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences. | Recruiting | Langfang | Hebei | 065001 | China | |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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| Overall Response Rate (ORR) | ORR is defined as the proportion of patients whose BOR is a CR or a partial response (PR) during the study assessed by the investigator according to 2014 Lugano Response Criteria for Malignant Lymphoma | Up to approximately 4 years |
| Disease Control Rate (DCR) | DCR is defined as the proportion of patients achieving CR, PR or stable disease (SD) during the study assessed by the investigator according to 2014 Lugano Response Criteria for Malignant Lymphoma | Up to approximately 4 years |
| Duration of Response (DoR) | DoR is defined as the time interval from the first occurrence of a documented objective response (CR or PR) to disease progression or death from any cause, whichever occurs first assessed by the investigator according to 2014 Lugano Response Criteria for Malignant Lymphoma | Up to approximately 4 years |
| Duration of Complete Response (DoCR) | DoCR is defined as the time interval from the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first | Up to approximately 4 years |
| Overall Survival (OS) | OS is defined as the time from treatment start of the Glofit-based regimen until the date of death from any cause | Up to approximately 4 years |
| Event-Free Survival (EFS) | EFS is defined as the time from treatment start of the Glofit-based regimen to any treatment failure including disease progression, relapse, initiation of new antilymphoma therapy (NALT), or death from any cause, which occurs first, as determined by the investigator assessment according to 2014 Lugano Response Criteria for Malignant Lymphoma | Up to approximately 4 years |
| Time to Next Treatment (TTNT) | TTNT is defined as the time from treatment start of the Glofit-based regimen to the initiation of next-line treatment | Up to approximately 4 years |
| Chinese Academy of Medical Sciences Hematology Hospital;Lymphoma Diagnosis and Treatment Center |
| Recruiting |
| Tianjin |
| Tianjin Municipality |
| 301636 |
| China |
| Peking University People's Hospital | Recruiting | Beijing | 100044 | China |
| Peking University Third Hospital | Recruiting | Beijing | 100191 | China |
| The First Bethune Hospital of Jilin University | Recruiting | Changchun | China |
| West China Hospital of Sichuan University | Recruiting | Chengdu | 610041 | China |
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | 510080 | China |
| Harbin Medical University Cancer Hospital | Recruiting | Harbin | 150081 | China |
| Shandong Cancer Hospital | Recruiting | Jinan | 250117 | China |
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | 200025 | China |
| Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | 200233 | China |
| Tianjin Cancer Hospital | Recruiting | Tianjin | 300060 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | 325035 | China |
| Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology | Recruiting | Wuhan | 430022 | China |
| Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology | Recruiting | Wuhan | 430030 | China |
| The First Affiliated Hospital of Xian Jiao Tong University | Recruiting | Xi'an | 710061 | China |
| Yantai Yu Huangding Hospital | Recruiting | Yantai | 264099 | China |
| Henan Cancer Hospital | Recruiting | Zhengzhou | 450008 | China |
| Queen Mary Hospital | Recruiting | Hong Kong | Hong Kong |
| 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 |
|---|---|
| C000720108 | glofitamab |
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