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Completed

NCT Number: NCT05886478

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

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.

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Key information

Conditions

T-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Saint Andre, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Drug

As this is an observational study, no intervention will be administered.

Primary outcomes

  1. Objective Response Rate (ORR) After First BV Administration

    Time frame: Up to approximately 12 months

  2. ORR After Re-Treatment

    Time frame: Up to approximately 12 months after BV retreatment

  3. Progression Free Survival (PFS) After First BV Administration

    Time frame: Up to approximately 24 months

  4. PFS After BV Re-Treatment

    Time frame: Up to approximately 24 months after BV retreatment

  5. 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

  6. TTNT After BV Re-Treatment

    Time frame: Up to approximately 24 months after BV retreatment

  7. Number of Participant With Grading of Motor Neuropathy During First BV Treatment

    Time frame: Up to approximately 12 months

  8. Time to Improvement of Motor Neuropathy During/ Post First BV Treatment

    Time frame: Up to approximately 24 months

  9. Time to Resolution of Motor Neuropathy During/ Post First BV Treatment

    Time frame: Up to approximately 24 months

  10. Number of Participants With Grading of Motor Neuropathy During BV Re-Treatment

    Time frame: Up to approximately 12 months after BV retreatment

  11. Time to Improvement of Motor Neuropathy During/ Post BV Re-Treatment

    Time frame: Up to approximately 16 months

  12. Time to Resolution of Motor Neuropathy During/ Post BV Re-Treatment

    Time frame: Up to approximately 24 months

  13. Number of Participants With Grading of Sensory Neuropathy During First BV Treatment

    Time frame: Up to approximately 12 months

  14. Time to Improvement of Sensory Neuropathy During/ Post First BV Treatment

    Time frame: Up to approximately 24 months

  15. Time to Resolution of Sensory Neuropathy During/ Post First BV Treatment

    Time frame: Up to approximately 24 months

  16. Number of Participants With Grading of Sensory Neuropathy During BV Re-Treatment

    Time frame: Up to approximately 12 months

  17. Time to Improvement of Sensory Neuropathy During/ Post BV Re-Treatment

    Time frame: Up to approximately 24 months

  18. Time to Resolution of Sensory Neuropathy During/ Post BV Re-Treatment

    Time frame: Up to approximately 24 months

  19. Number of Participants With Grading of Neutropenia During First BV Treatment

    Time frame: Up to approximately 12 months

  20. Number of Participants With Grading of Neutropenia During BV Re-Treatment

    Time frame: Up to approximately 12 months

  21. Number of Participants With Grading of Febrile Neutropenia During First BV Treatment

    Time frame: Up to approximately 24 months

  22. Number of Participants With Grading of Febrile Neutropenia During BV Re-Treatment

    Time frame: Up to approximately 12 months

  23. Number of Participants With Grading of Serious Infections During First BV Treatment

    Time frame: Up to approximately 12 months

  24. Number of Participants With Grading of Serious Infections During BV Re-Treatment

    Time frame: Up to approximately 12 months

Secondary outcomes

  1. Number of Participants With Cutaneous Lymphoma Co-Medications or Strategies Used to Treat CTCL Disease

    Time frame: Up to approximately 12 months

  2. Amount of BV Dose

    Time frame: Up to approximately 12 months

  3. Number of Cycles of BV Administered

    Time frame: Up to approximately 12 months

  4. Time Interval Between BV Administration

    Time frame: Up to approximately 24 months

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 2, 2023
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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