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Sponsor administrative decision
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Retrospective and prospective multi-center observational study of patients with B-cell lymphomas treated with loncastuximab tesirine treatment in real-world practice.
The purpose of this study is to assess treatment patterns and generate evidence on the effectiveness and safety of loncastuximab tesirine treatment in real-world practice. This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Treated with Loncastuximab Tesirine | Patients with B-cell lymphomas and other diagnoses who have been treated with loncastuximab tesirine will have their medical chart data entered into the registry. |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Up to 48 Months | |
| Overall Survival (OS) | Up to 48 Months | |
| Duration of Response (DoR) | Up to 48 Months | |
| Overall Response Rate (ORR) | Up to 48 Months | |
| Time to Partial Response (PR) | Up to 48 Months | |
| Time to Complete Response (CR) | Up to 48 Months | |
| Time to Disease Progression | Up to 48 Months | |
| Number of Patients with Adverse Events | Includes serious adverse events (SAEs) and adverse events (AEs) Grade 3 or higher for the events of: edema, myelosuppression, infections, and cutaneous reactions. | Up to 48 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Hospitalizations | Up to 48 Months | |
| Duration of Hospitalizations | Up to 48 Months | |
| Reasons for Hospitalizations |
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Inclusion Criteria:
Exclusion Criteria:
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Patients initiated or initiating commercially available loncastuximab tesirine treatment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Compassionate Cancer Care Medical Group | Fountain Valley | California | 92708 | United States |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| Up to 48 Months |
| Number of Surgeries | Up to 48 Months |
| Type of Surgeries | Up to 48 Months |
| Reasons for Surgeries | Up to 48 Months |
| Number of Emergency Room Visits | Up to 48 Months |
| Reasons for Emergency Room Visits | Up to 48 Months |
| Number of Outpatient Visits | Up to 48 Months |
| Reasons for Outpatient Visits | Up to 48 Months |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |