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The purpose of this study is to evaluate the efficacy and safety of MDV9300 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that have achieved either stable disease or a partial remission following definitive salvage therapy.
Two cohorts of patients will be enrolled: a cohort treated with salvage chemotherapy but considered ineligible for autologous stem cell transplant (ASCT), and a cohort of patients who have received ASCT following salvage chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDV9300 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDV9300 | Biological | MDV9300 will be administered at a dose of 200 mg by intravenous (IV) infusion every 2 weeks until treatment discontinuation criteria are met. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best overall response rate | Defined as the proportion of patients in the intent-to-treat population with a complete response (CR) or partial response (PR) attributable to study treatment, as assessed by the independent review committee (IRC). | no later than 6 months after the last patient is enrolled in a cohort |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response (for responders) | Defined as the time from the first objective evidence of CR or PR as assessed by the IRC to the first objective evidence of disease progression or death due to any cause, whichever occurs first. | no later than 6 months after the last patient is enrolled in a cohort |
| Progression-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nashville | Tennessee | 37203 | United States |
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Defined as the time from the date of first study drug infusion to the first objective evidence of disease progression or death due to any cause, whichever occurs first. |
| no later than 6 months after the last patient is enrolled in a cohort |
| Time to response (for responders) | Defined as the time from the date of first study drug infusion to the first objective evidence of CR or PR as assessed by the IRC. | no later than 6 months after the last patient is enrolled in a cohort |
| Overall survival | Defined as the time from the date of first study drug infusion to death due to any cause. | no later than 6 months after the last patient is enrolled in a cohort |
| Composite of safety | Safety will be evaluated by incidence and severity of adverse events, including serious adverse events and incidence of permanent treatment discontinuation due to adverse events. | no later than 6 months after the last patient is enrolled in a cohort |
| 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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