A Study in Adults With Cutaneous T-cell Lymphoma (CTCL) Retreated With Brentuximab Vedotin

Study Overview
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Brief Summary
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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
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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.

Official Title
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Real-World Evidence Study on Brentuximab Vedotin Retreatment Outcomes of Cutaneous T-cell Lymphoma Patients

Conditions
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T-Cell Lymphoma

Intervention / Treatment
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* Drug: No intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Brentuximab Vedotin<br>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<br>* As this is an observational study, no intervention will be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Therapy