A Study in Adults With Cutaneous T-cell Lymphoma (CTCL) Retreated With Brentuximab Vedotin
- Registration Number
- NCT05886478
- Lead Sponsor
- Takeda
- Brief Summary
The main aim of this study is to describe how effective and safe the re-treatment of adults with cutaneous T-cell lymphoma (CTCL) with brentuximab vedotin is. Another aim is to describe treatment patterns of persons with CTCL who have received brentuximab vedotin again.
No treatment will be provided during this study. Information already existing in the participants' medical charts will be reviewed and collected.
- Detailed Description
This is a non-interventional, retrospective study of participants from France, Germany, Spain and Italy with CTCL who were retreated with brentuximab vedotin (BV) after a relapse in at least two different lines of therapy. The participants will be identified from their medical charts and those who meet the eligibility criteria will be included.
The study will enroll approximately 50 participants.
This multi-center trial will be conducted in Europe. The participants are assessed after the last dose of BV for approximately 4 months and followed up for at least 12 months after the re-treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Brentuximab Vedotin No intervention Participants with CTCL who were retreated with BV after relapse will be observed retrospectively and the outcomes will be observed from June 2023 to September 2023.
- Primary Outcome Measures
Name Time Method Time to Next Treatment (TTNT) After First BV Administration (Regardless of Type of Next Treatment, i.e., BV or non-BV) Up to approximately 16 months TTNT After BV Re-Treatment Up to approximately 24 months after BV retreatment Number of Participant With Grading of Motor Neuropathy During First BV Treatment Up to approximately 12 months Time to Improvement of Motor Neuropathy During/ Post BV Re-Treatment Up to approximately 16 months Objective Response Rate (ORR) After First BV Administration Up to approximately 12 months Progression Free Survival (PFS) After First BV Administration Up to approximately 24 months Time to Improvement of Motor Neuropathy During/ Post First BV Treatment Up to approximately 24 months Number of Participants With Grading of Motor Neuropathy During BV Re-Treatment Up to approximately 12 months after BV retreatment Time to Improvement of Sensory Neuropathy During/ Post First BV Treatment Up to approximately 24 months Time to Resolution of Sensory Neuropathy During/ Post First BV Treatment Up to approximately 24 months Time to Resolution of Sensory Neuropathy During/ Post BV Re-Treatment Up to approximately 24 months PFS After BV Re-Treatment Up to approximately 24 months after BV retreatment Number of Participants With Grading of Sensory Neuropathy During First BV Treatment Up to approximately 12 months Number of Participants With Grading of Sensory Neuropathy During BV Re-Treatment Up to approximately 12 months Time to Improvement of Sensory Neuropathy During/ Post BV Re-Treatment Up to approximately 24 months Number of Participants With Grading of Neutropenia During First BV Treatment Up to approximately 12 months Number of Participants With Grading of Febrile Neutropenia During BV Re-Treatment Up to approximately 12 months Number of Participants With Grading of Serious Infections During First BV Treatment Up to approximately 12 months Number of Participants With Grading of Serious Infections During BV Re-Treatment Up to approximately 12 months ORR After Re-Treatment Up to approximately 12 months after BV retreatment Time to Resolution of Motor Neuropathy During/ Post First BV Treatment Up to approximately 24 months Number of Participants With Grading of Neutropenia During BV Re-Treatment Up to approximately 12 months Number of Participants With Grading of Febrile Neutropenia During First BV Treatment Up to approximately 24 months Time to Resolution of Motor Neuropathy During/ Post BV Re-Treatment Up to approximately 24 months
- Secondary Outcome Measures
Name Time Method Number of Cycles of BV Administered Up to approximately 12 months Time Interval Between BV Administration Up to approximately 24 months Amount of BV Dose Up to approximately 12 months Number of Participants With Cutaneous Lymphoma Co-Medications or Strategies Used to Treat CTCL Disease Up to approximately 12 months
Trial Locations
- Locations (11)
Universitätsmedizin Göttingen
🇩🇪Göttingen, Germany
Hopital Saint Andre
🇫🇷Bordeaux, France
Hopital Saint Louis
🇫🇷Paris, France
CHU Roeun
🇫🇷Rouen, France
Klinikum Ludwigshafen, Hautklinik
🇩🇪Ludwigshafen, Germany
Universitätsklinikum Würzburg
🇩🇪Würzburg, Germany
Ospedale Maggiore Policlinico
🇮🇹Milan, Italy
AZ OSP Citta' Della Salute (Torino)
🇮🇹Torino, Italy
Hospital Clinic, Barcelona
🇪🇸Barcelona, Spain
ICO Hospitalet, Barcelona
🇪🇸Barcelona, Spain
Hospital Son Espases
🇪🇸Palma, Spain