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.
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 Type
OBSERVATIONAL
Enrollment
26
As this is an observational study, no intervention will be administered.
Hopital Saint Andre
Bordeaux, France
Hopital Saint Louis
Paris, France
CHU Roeun
Rouen, France
Universitätsmedizin Göttingen
Göttingen, Germany
Objective Response Rate (ORR) After First BV Administration
Time frame: Up to approximately 12 months
ORR After Re-Treatment
Time frame: Up to approximately 12 months after BV retreatment
Progression Free Survival (PFS) After First BV Administration
Time frame: Up to approximately 24 months
PFS After BV Re-Treatment
Time frame: 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)
Time frame: Up to approximately 16 months
TTNT After BV Re-Treatment
Time frame: Up to approximately 24 months after BV retreatment
Number of Participant With Grading of Motor Neuropathy During First BV Treatment
Time frame: Up to approximately 12 months
Time to Improvement of Motor Neuropathy During/ Post First BV Treatment
Time frame: Up to approximately 24 months
Time to Resolution of Motor Neuropathy During/ Post First BV Treatment
Time frame: Up to approximately 24 months
Number of Participants With Grading of Motor Neuropathy During BV Re-Treatment
Time frame: Up to approximately 12 months after BV retreatment
Time to Improvement of Motor Neuropathy During/ Post BV Re-Treatment
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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
...and 1 more locations
Time frame: Up to approximately 16 months
Time to Resolution of Motor Neuropathy During/ Post BV Re-Treatment
Time frame: Up to approximately 24 months
Number of Participants With Grading of Sensory Neuropathy During First BV Treatment
Time frame: Up to approximately 12 months
Time to Improvement of Sensory Neuropathy During/ Post First BV Treatment
Time frame: Up to approximately 24 months
Time to Resolution of Sensory Neuropathy During/ Post First BV Treatment
Time frame: Up to approximately 24 months
Number of Participants With Grading of Sensory Neuropathy During BV Re-Treatment
Time frame: Up to approximately 12 months
Time to Improvement of Sensory Neuropathy During/ Post BV Re-Treatment
Time frame: Up to approximately 24 months
Time to Resolution of Sensory Neuropathy During/ Post BV Re-Treatment
Time frame: Up to approximately 24 months
Number of Participants With Grading of Neutropenia During First BV Treatment
Time frame: Up to approximately 12 months
Number of Participants With Grading of Neutropenia During BV Re-Treatment
Time frame: Up to approximately 12 months
Number of Participants With Grading of Febrile Neutropenia During First BV Treatment
Time frame: Up to approximately 24 months
Number of Participants With Grading of Febrile Neutropenia During BV Re-Treatment
Time frame: Up to approximately 12 months
Number of Participants With Grading of Serious Infections During First BV Treatment
Time frame: Up to approximately 12 months
Number of Participants With Grading of Serious Infections During BV Re-Treatment
Time frame: Up to approximately 12 months
Number of Participants With Cutaneous Lymphoma Co-Medications or Strategies Used to Treat CTCL Disease
Time frame: Up to approximately 12 months
Amount of BV Dose
Time frame: Up to approximately 12 months
Number of Cycles of BV Administered
Time frame: Up to approximately 12 months
Time Interval Between BV Administration
Time frame: Up to approximately 24 months