A Study in Adults With Cutaneous T-cell Lymphoma (CTCL) Retreated With Brentuximab Vedotin
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Brentuximab Vedotin 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. |
Drug: No intervention
As this is an observational study, no intervention will be administered.
|
Outcome Measures
Primary Outcome Measures
- Objective Response Rate (ORR) After First BV Administration [Up to approximately 12 months]
- ORR After Re-Treatment [Up to approximately 12 months after BV retreatment]
- Progression Free Survival (PFS) After First BV Administration [Up to approximately 24 months]
- PFS After BV Re-Treatment [Up to approximately 24 months after BV retreatment]
- 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 First BV Treatment [Up to approximately 24 months]
- Time to Resolution 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 Motor Neuropathy During/ Post BV Re-Treatment [Up to approximately 16 months]
- Time to Resolution of Motor Neuropathy During/ Post BV Re-Treatment [Up to approximately 24 months]
- Number of Participants With Grading of Sensory Neuropathy During First BV Treatment [Up to approximately 12 months]
- 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]
- 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]
- Time to Resolution 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 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]
- 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]
Secondary Outcome Measures
- Number of Participants With Cutaneous Lymphoma Co-Medications or Strategies Used to Treat CTCL Disease [Up to approximately 12 months]
- Amount of BV Dose [Up to approximately 12 months]
- Number of Cycles of BV Administered [Up to approximately 12 months]
- Time Interval Between BV Administration [Up to approximately 24 months]
Eligibility Criteria
Criteria
Inclusion criteria:
-
Participant with a confirmed diagnosis of CTCL (including Mycosis fungoides (MF), Sézary syndrome (SS), Primary cutaneous CD30+ anaplastic large cell lymphoma (pcALCL) and others) who reached a complete response (CR), partial response (PR) or stable disease (SD) on a previous treatment with BV and whose disease relapsed
-
Participant who was treated with BV in at least 2 lines of therapy, other treatments could have been administered in between
-
Participant has received three or more cycles of BV in retreatment
Exclusion criteria:
There are no exclusion criteria for this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hopital Saint Andre | Bordeaux | France | 33075 | |
| 2 | Hopital Saint Louis | Paris | France | 75010 | |
| 3 | CHU Roeun | Rouen | France | 76031 | |
| 4 | Universitätsmedizin Göttingen | Göttingen | Germany | 37075 | |
| 5 | Klinikum Ludwigshafen, Hautklinik | Ludwigshafen | Germany | 67063 | |
| 6 | Universitätsklinikum Würzburg | Würzburg | Germany | 97080 | |
| 7 | Ospedale Maggiore Policlinico | Milan | Italy | 20122 | |
| 8 | AZ OSP Citta' Della Salute (Torino) | Torino | Italy | 10126 | |
| 9 | Hospital Clinic, Barcelona | Barcelona | Spain | 08036 | |
| 10 | ICO Hospitalet, Barcelona | Barcelona | Spain | 08908 | |
| 11 | Hospital Son Espases | Palma | Spain | 07120 |
Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Brentuximab-5020