B-Cell Lymphomas
Conditions
Keywords
Diffuse Large B-Cell Lymphoma, Loncastuximab tesirine, Non-Hodgkin Lymphoma, Relapsed/Refractory Diffuse Large B-Cell Lymphoma
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.).
Interventions
None listed
Sponsors
ADC Therapeutics S.A.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 48 Months | Includes serious adverse events (SAEs) and adverse events (AEs) Grade 3 or higher for the events of: edema, myelosuppression, infections, and cutaneous reactions. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Outpatient Visits | Up to 48 Months |
| Number of Hospitalizations | Up to 48 Months |
| Reasons for Outpatient Visits | 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 |
Countries
United States
Outcome results
None listed