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The purpose of this study is to assess the efficacy and safety in the real-world settings of glofitamab in combination with salvage therapy among Chinese adult patients with relapsed or refractory B-cell non-hodgkin lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glofitamab | Drug | Glofitamab will be administered at the discretion of the physician per local clinical practice and local labeling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Complete Response Rate (bCRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | Baseline up to EOT (approximately 9 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response Rate (bORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | Baseline up to EOT (approximately 9 months) | |
| 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 24 months) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who will be treated with glofitamab (known as being recommended and having the intention to be treated with glofitamab at the time of signing informed consent) or have initiated glofitamab treatment within three months prior to enrollment and after the indication approval will be observed in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiwen Huang | Contact | 0512-80668050 | huanghaiwen@suda.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
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| Duration of Complete Response (DoCR) | From the date of the first occurrence of a documented CR to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 24 months) |
| PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | Baseline up to end of study (approximately 24 months) |
| Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma | From the start of glofitamab 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 24 months) |
| Overall Survival (OS) | From the start of glofitamab treatment until the date of death from any cause (up to approximately 24 months) |
| Time to Next Treatment (TTNT) | From the start of glofitamab treatment to the initiation of next-line treatment (up to approximately 24 months) |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-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 |
|---|---|
| C000720108 | glofitamab |
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