Long-term Registry of Patients Treated With Loncastuximab Tesirine

NCT05160064 | Withdrawn

• 1 other identifier: ADCT-402-N01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

B-Cell Lymphomas

Keywords

Diffuse Large B-Cell Lymphoma; Loncastuximab tesirine; Non-Hodgkin Lymphoma; Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (10)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients initiated or initiating commercially available loncastuximab tesirine treatment.

You may qualify if:

• 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.

You may not qualify if:

• Prior loncastuximab tesirine exposure in clinical trials.

Sponsors & Collaborators

• ADC Therapeutics S.A.: lead

Study Sites (1)

Compassionate Cancer Care Medical Group

Fountain Valley, California, 92708, United States

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 48 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 16, 2021
• Study Start: June 30, 2022
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)