Long-term Registry of Patients Treated With Loncastuximab Tesirine
- Conditions
- B-Cell Lymphomas
- Registration Number
- NCT05160064
- Lead Sponsor
- ADC Therapeutics S.A.
- 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.).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- Prior loncastuximab tesirine exposure in clinical trials.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
Time to Partial Response (PR) Up to 48 Months Time to Complete Response (CR) Up to 48 Months Progression-free Survival (PFS) Up to 48 Months Overall Survival (OS) Up to 48 Months Overall Response Rate (ORR) Up to 48 Months Duration of Response (DoR) Up to 48 Months Time to Disease Progression Up to 48 Months
- Secondary Outcome Measures
Name Time Method Number of Hospitalizations Up to 48 Months Reasons for Surgeries Up to 48 Months Reasons for Outpatient Visits Up to 48 Months Number of Surgeries Up to 48 Months Reasons for Emergency Room Visits Up to 48 Months Number of Outpatient Visits Up to 48 Months Duration of Hospitalizations Up to 48 Months Number of Emergency Room Visits Up to 48 Months Reasons for Hospitalizations Up to 48 Months Type of Surgeries Up to 48 Months
Trial Locations
- Locations (1)
Compassionate Cancer Care Medical Group
🇺🇸Fountain Valley, California, United States