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

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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

Study Description
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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.


Condition or disease Intervention/treatment
T-Cell Lymphoma 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 Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Real-World Evidence Study on Brentuximab Vedotin Retreatment Outcomes of Cutaneous T-cell Lymphoma Patients
Actual Study Start Date : February 8, 2024
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05886478


Contacts
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Contact: Takeda Contact +1-877-825-3327 medinfoUS@takeda.com

Locations
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France
Hopital Saint Andre Not yet recruiting
Bordeaux, France, 33075
Contact: Site Contact    +33 5 57 82 25 00    mailto:marie.beylot-barry@chu-bordeaux.fr   
Principal Investigator: Marie BEYLOT-BARRY         
Hopital Saint Louis Recruiting
Paris, France, 75010
Contact: Site Contact    +33 7 67 18 89 76    mailto:adele.demasson@aphp.fr   
Principal Investigator: Adele DE MASSON         
CHU Roeun Not yet recruiting
Rouen, France, 76031
Contact: Site Contact    +33 2 32 88 66 99    mailto:anne-benedicte.duval-modeste@chu-rouen.fr   
Principal Investigator: ANNE-BENEDICTE DUVAL MODESTE         
Germany
Universitätsmedizin Göttingen Recruiting
Göttingen, Germany, 37075
Contact: Site Contact    +49 551 3962005    mailto:christina.mitteldorf@med.uni-goettingen.de   
Principal Investigator: Christina Mitteldorf         
Klinikum Ludwigshafen, Hautklinik Not yet recruiting
Ludwigshafen, Germany, 67063
Contact: Site Contact    +496215033350    mailto:dippele@klilu.de   
Principal Investigator: Edgar Dippel         
Universitätsklinikum Würzburg Recruiting
Würzburg, Germany, 97080
Contact: Site Contact    +49-931-201-26351    mailto:Wobser_m@ukw.de   
Principal Investigator: Marion Wobser         
Italy
Ospedale Maggiore Policlinico Not yet recruiting
Milan, Italy, 20122
Contact: Site Contact    +39 0255033742    mailto:giorgia.saporiti@policlinico.mi.it   
Principal Investigator: Giorgia Saporini         
AZ OSP Citta' Della Salute (Torino) Not yet recruiting
Torino, Italy, 10126
Contact: Site Contact    +39 0116335858    mailto:pietro.quaglino@unito.it   
Principal Investigator: PIETRO QUAGLINO         
Spain
Hospital Clinic, Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Site Contact    +34 932 27 54 00 ext 2618    mailto:acombalia@clinic.cat   
Principal Investigator: ANDREA COMBALIA         
ICO Hospitalet, Barcelona Not yet recruiting
Barcelona, Spain, 08908
Contact: Site Contact       mailto:e.gonzalez@iconcologia.net   
Principal Investigator: EVA GONZALEZ BARCA         
Hospital Son Espases Recruiting
Palma, Spain, 07120
Contact: Site Contact    +34 659882108    mailto:antoniom.gutierrez@ssib.es   
Principal Investigator: Antonio Gutierrez         
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda
More Information
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Additional Information:

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT05886478    
Other Study ID Numbers: Brentuximab-5020
First Posted: June 2, 2023    Key Record Dates
Last Update Posted: March 6, 2024
Last Verified: March 2024
Individual Participant Data (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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, T-Cell, Cutaneous
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin