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Primary Objective:
To evaluate objective response rate (ORR) in adult patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL) who receive systemic treatment after at least 2 prior systemic therapies in the real-world setting according to Lugano classification of malignant lymphoma (Cheson, 2014) and as assessed by independent central review
Secondary Objectives:
To evaluate the following outcomes in adult patients with r/r DLBCL who are treated with currently available therapies in the real-world setting:
ORR according to Lugano classification and as assessed by treating physician evaluation
Complete Response (CR) rate according to Lugano classification and as assessed by:
Progression Free Survival (PFS) according to Lugano classification and as assessed by:
Overall Survival (OS)
Duration of response (DOR) according to Lugano classification and as assessed by
Disease control rate (DCR) according to Lugano classification and as assessed by:
Time to next treatment (TTNT)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants with r/r DLBCL who were treated with at least 2 prior systemic therapies in the real-world setting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional | Other | No study treatment will be administered on this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | The proportion of best overall response of complete response (CR) or partial response (PR). | Up to 84 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) rate | The proportion of patients with a CR after initiation of the selected line of therapy (LoT). | Up to 84 months |
| Progression Free Survival (PFS) | The time from the start date of the selected LoT until the first date of progressive disease (PD) or death due to any cause, whichever occurs first. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria apply
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Adult participants with DLBCL who have relapsed after or are refractory to at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Research Facility | Graz | 38 8036 | Austria | |||
| Regeneron Research Facility |
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| Up to 84 months |
| Overall Survival (OS) | The time from the start date of the selected LoT until death due to any cause. | Up to 84 months |
| Duration of Response (DOR) | The time from the date of the first documented CR or PR until the first date of PD or death due to any cause, whichever occurs first. | Up to 84 months |
| Disease Control Rate (DCR) | The proportion of patients who achieve a best overall response of CR, PR, or stable disease (SD). | Up to 84 months |
| Time to Next Treatment (TTNT) | The time from the start date of the selected LoT to the start of a new antineoplastic treatment line. | Up to 84 months |
| Caen |
| 14033 |
| France |
| Regeneron Research Facility | Paris | 75010 | France |
| Regeneron Research Facility | Pierre-Bénite | 69310 | France |
| Regeneron Research Facility | Essen | 45147 | Germany |
| Regeneron Research Facility | Frankfurt | 60590 | Germany |
| Regeneron Research Facility | London | EC1A 7BE | United Kingdom |
| Regeneron Research Facility | Manchester | M20 4BX | United Kingdom |
| Regeneron Research Facility | Nottingham | NG5 1PB | United Kingdom |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D012008 | Recurrence |
| D008228 | Lymphoma, Non-Hodgkin |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
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