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This study will evaluate the pharmacokinetics, safety, tolerability, and efficacy of glofitamab as a single agent following a fixed single dose of obinutuzumab in Chinese patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have failed two or more lines of systemic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R/R DLBCL | Experimental | Participants will receive a fixed dose of obinutuzumab pre-treatment followed by glofitamab on Cycle 1 Days 8 and 15, then every 3 weeks (Q3W) from Cycles 2-12 (cycle length = 21 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obinutuzumab | Drug | Participants will receive 1000 mg of intravenous (IV) obinutuzumab on Cycle 1 Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) | Up to 3.5 years | |
| Serum Concentration of Glofitamab | At pre-defined intervals up to 3.5 years | |
| Total Exposure (AUC) of Glofitamab | At pre-defined intervals up to 3.5 years | |
| Maximum Serum Concentration (Cmax) of Glofitamab | At pre-defined intervals up to 3.5 years | |
| Minimum Serum Concentration (Cmin) of Glofitamab | At pre-defined intervals up to 3.5 years | |
| Clearance of Glofitamab | At pre-defined intervals up to 3.5 years | |
| Volume of Distribution at Steady State (Vss) of Glofitamab | At pre-defined intervals up to 3.5 years | |
| Half-life (T1/2) of Glofitamab | At pre-defined intervals up to 3.5 years | |
| Complete Response Rate (CRR) as Assessed by an Independent Review Committee (IRC) | Up to 3.5 years | |
| Percentage of Participants with Anti-Drug Antibodies (ADA) | Up to 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-Assessed CRR | Up to 3.5 years | |
| Objective Response Rate (ORR) as Assessed by IRC | Up to 3.5 years | |
| ORR as Assessed by Investigator |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | 100142 | China | |||
| Peking University Third Hospital |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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| Glofitamab | Drug | Participants will receive 2.5 mg of IV glofitamab Cycle 1 Day 8, 10 mg at Cycle 1 Day 15, and 30 mg on Day 1 of Cycles 2-12 Q3W (cycle length = 21 days). |
|
| Tocilizumab | Drug | Participants will receive tocilizumab as needed to manage cytokine release syndrome (CRS). |
|
| Up to 3.5 years |
| Duration of Objective Response (DOR) as Assessed by IRC and Investigator | Up to 3.5 years |
| Duration of Complete Response (CR) as Assessed by IRC and Investigator | Up to 3.5 years |
| Progression-Free Survival (PFS) as Determined by IRC and Investigator | Up to 3.5 years |
| Overall Survival (OS) | Up to 3.5 years |
| Time to First Overall Response (TFOR) as Assessed by IRC and Investigator | Up to 3.5 years |
| Time to First Complete Response (TFCR) as Assessed by IRC and Investigator | Up to 3.5 years |
| Beijing |
| 100191 |
| China |
| Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology | Guangzhou | 510060 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| Jiangsu Province Hospital | Nanjing | 210008 | China |
| Tianjin Cancer Hospital | Tianjin | 300060 | China |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| 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 |
|---|---|
| C543332 | obinutuzumab |
| C000720108 | glofitamab |
| C502936 | tocilizumab |
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