Long-term Registry of Patients Treated With Loncastuximab Tesirine

B-Cell Lymphomas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05160064
• Other study ID #: ADCT-402-N01
• Status: Withdrawn
• Start date: June 30, 2022
• Est. completion date: January 2025

Study information

• Verified date: June 2022
• Source: ADC Therapeutics S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• B-Cell Lymphomas
• Lymphoma
• Lymphoma, B-Cell

Locations

Country	Name	City	State
United States	Compassionate Cancer Care Medical Group	Fountain Valley	California

Sponsors (1)

Lead Sponsor	Collaborator
ADC Therapeutics S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS)		Up to 48 Months
Primary	Overall Survival (OS)		Up to 48 Months
Primary	Duration of Response (DoR)		Up to 48 Months
Primary	Overall Response Rate (ORR)		Up to 48 Months
Primary	Time to Partial Response (PR)		Up to 48 Months
Primary	Time to Complete Response (CR)		Up to 48 Months
Primary	Time to Disease Progression		Up to 48 Months
Primary	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	Number of Hospitalizations		Up to 48 Months
Secondary	Duration of Hospitalizations		Up to 48 Months
Secondary	Reasons for Hospitalizations		Up to 48 Months
Secondary	Number of Surgeries		Up to 48 Months
Secondary	Type of Surgeries		Up to 48 Months
Secondary	Reasons for Surgeries		Up to 48 Months
Secondary	Number of Emergency Room Visits		Up to 48 Months
Secondary	Reasons for Emergency Room Visits		Up to 48 Months
Secondary	Number of Outpatient Visits		Up to 48 Months
Secondary	Reasons for Outpatient Visits		Up to 48 Months