Clinical trial NCT05160064: Long-term Registry of Patients Treated With Loncastuximab Tesirine
Official title: Long-term Longitudinal Cohort Registry of Patients Treated With Loncastuximab Tesirine
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: B-Cell Lymphomas
Keywords: Diffuse Large B-Cell Lymphoma
Loncastuximab tesirine
Non-Hodgkin Lymphoma
Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Lead sponsor: ADC Therapeutics S.A.
Sponsor class: INDUSTRY
First posted: 2021-12-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients initiated or initiating commercially available loncastuximab tesirine treatment.

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.).

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.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to 48 Months
measure: Overall Survival (OS)
timeFrame: Up to 48 Months
measure: Duration of Response (DoR)
timeFrame: Up to 48 Months
measure: Overall Response Rate (ORR)
timeFrame: Up to 48 Months
measure: Time to Partial Response (PR)
timeFrame: Up to 48 Months
measure: Time to Complete Response (CR)
timeFrame: Up to 48 Months
measure: Time to Disease Progression
timeFrame: Up to 48 Months
measure: Number of Patients with Adverse Events
timeFrame: Up to 48 Months
Secondary outcomes:
measure: Number of Hospitalizations
timeFrame: Up to 48 Months
measure: Duration of Hospitalizations
timeFrame: Up to 48 Months
measure: Reasons for Hospitalizations
timeFrame: Up to 48 Months
measure: Number of Surgeries
timeFrame: Up to 48 Months
measure: Type of Surgeries
timeFrame: Up to 48 Months
measure: Reasons for Surgeries
timeFrame: Up to 48 Months
measure: Number of Emergency Room Visits
timeFrame: Up to 48 Months
measure: Reasons for Emergency Room Visits
timeFrame: Up to 48 Months
measure: Number of Outpatient Visits
timeFrame: Up to 48 Months
measure: Reasons for Outpatient Visits
timeFrame: Up to 48 Months
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Compassionate Cancer Care Medical Group
state: California
Study officials:
References: