Long-term Registry of Patients Treated With Loncastuximab Tesirine

Study Overview
=================
Brief Summary
-----------------
Retrospective and prospective multi-center observational study of patients with B-cell lymphomas treated with loncastuximab tesirine treatment in real-world practice.

Detailed Description
-----------------
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.).

Official Title
-----------------
Long-term Longitudinal Cohort Registry of Patients Treated With Loncastuximab Tesirine

Conditions
-----------------
B-Cell Lymphomas

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be ≥ 18 years of age at the time of consent. Initiated or initiating commercially available loncastuximab tesirine treatment. Written informed consent must be obtained prior to any registry activities. Exclusion Criteria: Prior loncastuximab tesirine exposure in clinical trials.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients Treated with Loncastuximab Tesirine<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Hospitalizations |  | Up to 48 Months | 
| Duration of Hospitalizations |  | Up to 48 Months | 
| Reasons for Hospitalizations |  | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma, Loncastuximab tesirine, Relapsed/Refractory Diffuse Large B-Cell Lymphoma