Long-term Registry of Patients Treated With Loncastuximab Tesirine

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

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

Study Overview

• Status: Withdrawn
• Conditions: B-Cell Lymphomas

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.).

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • Fountain Valley, California, United States, 92708
      • Compassionate Cancer Care Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients initiated or initiating commercially available loncastuximab tesirine treatment.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

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	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

Collaborators and Investigators

• Sponsor: ADC Therapeutics S.A.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 30, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 3, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Non-Hodgkin Lymphoma; Diffuse Large B-Cell Lymphoma; Loncastuximab tesirine; Relapsed/Refractory Diffuse Large B-Cell Lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell
• Other Study ID Numbers: ADCT-402-N01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No