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

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

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.

Study Overview

• Status: Completed
• Conditions: T-Cell Lymphoma
• Intervention / Treatment: Drug: No intervention

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 Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33075
    • Hopital Saint André
  • Paris, France, 75010
    • Hopital Saint Louis
  • Rouen, France, 76031
    • CHU Roeun
• Germany
  • Göttingen, Germany, 37075
    • Universitatsmedizin Gottingen
  • Ludwigshafen, Germany, 67063
    • Klinikum Ludwigshafen, Hautklinik
  • Würzburg, Germany, 97080
    • Universitatsklinikum Wurzburg
• Italy
  • Milan, Italy, 20122
    • Ospedale Maggiore Policlinico
  • Torino, Italy, 10126
    • AZ OSP Citta' Della Salute (Torino)
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic, Barcelona
  • Barcelona, Spain, 08908
    • ICO Hospitalet, Barcelona
  • Palma, Spain, 07120
    • Hospital Son Espases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants diagnosed with CTCL who were retreated with BV after relapse in France, Germany, Spain, and Italy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2024
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
• Other Study ID Numbers: Brentuximab-5020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No