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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05886478
Recruitment Status : Recruiting
First Posted : June 2, 2023
Last Update Posted : March 6, 2024
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date May 24, 2023
First Posted Date June 2, 2023
Last Update Posted Date March 6, 2024
Actual Study Start Date February 8, 2024
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 24, 2023)
  • 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 [ 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 24, 2023)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study in Adults With Cutaneous T-cell Lymphoma (CTCL) Retreated With Brentuximab Vedotin
Official Title Real-World Evidence Study on Brentuximab Vedotin Retreatment Outcomes of Cutaneous T-cell Lymphoma Patients
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.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants diagnosed with CTCL who were retreated with BV after relapse in France, Germany, Spain, and Italy.
Condition T-Cell Lymphoma
Intervention Drug: No intervention
As this is an observational study, no intervention will be administered.
Study Groups/Cohorts 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.
Intervention: Drug: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 24, 2023)		 50
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2024
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Takeda Contact +1-877-825-3327 medinfoUS@takeda.com
Listed Location Countries France,   Germany,   Italy,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT05886478
Other Study ID Numbers Brentuximab-5020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
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.
URL: https://vivli.org/ourmember/takeda/
Current Responsible Party Takeda
Original Responsible Party Same as current
Current Study Sponsor Takeda
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Study Director Takeda
PRS Account Takeda
Verification Date March 2024