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History of Changes for Study: NCT05886478
A Study in Adults With Cutaneous T-cell Lymphoma (CTCL) Retreated With Brentuximab Vedotin
Latest version (submitted March 5, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 24, 2023 None (earliest Version on record)
2 June 12, 2023 Study Status and References
3 October 13, 2023 Study Status
4 December 11, 2023 Study Status
5 March 5, 2024 Recruitment Status, Study Status, Contacts/Locations and Oversight
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Study NCT05886478
Submitted Date:  May 24, 2023 (v1)
Open or close this module Study Identification
Unique Protocol ID: Brentuximab-5020
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
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2023
Overall Status: Not yet recruiting
Study Start: May 24, 2023
Primary Completion: August 10, 2023 [Anticipated]
Study Completion: August 10, 2023 [Anticipated]
First Submitted: May 24, 2023
First Submitted that
Met QC Criteria:		 May 24, 2023
First Posted: June 2, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:		 May 24, 2023
Last Update Posted: June 2, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Takeda
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: T-Cell Lymphoma
Keywords: Drug Therapy
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Retrospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 50 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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.
Open or close this module Outcome Measures
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 ]
Open or close this module Eligibility
Study Population: Participants diagnosed with CTCL who were retreated with BV after relapse in France, Germany, Spain, and Italy.
Sampling Method: Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Takeda Contact
Telephone: +1-877-825-3327
Email: medinfoUS@takeda.com
Study Officials: Study Director
Study Director
Takeda
Locations: France
Hopital Saint Andre
Bordeaux, France, 33075
Contact:Contact: Site Contact +33 5 57 82 25 00 mailto:marie.beylot-barry@chu-bordeaux.fr
Contact:Principal Investigator: Marie BEYLOT-BARRY
Hopital Saint Louis
Paris, France, 75010
Contact:Contact: Site Contact +33 7 67 18 89 76 mailto:adele.demasson@aphp.fr
Contact:Principal Investigator: Adele DE MASSON
CHU Roeun
Rouen, France, 76031
Contact:Contact: Site Contact +33 2 32 88 66 99 mailto:anne-benedicte.duval-modeste@chu-rouen.fr
Contact:Principal Investigator: ANNE-BENEDICTE DUVAL MODESTE
Germany
Universitätsmedizin Göttingen
Göttingen, Germany, 37075
Contact:Contact: Site Contact +49 551 3962005 mailto:christina.mitteldorf@med.uni-goettingen.de
Contact:Principal Investigator: Christina Mitteldorf
Klinikum Ludwigshafen, Hautklinik
Ludwigshafen, Germany, 67063
Contact:Contact: Site Contact +496215033350 mailto:dippele@klilu.de
Contact:Principal Investigator: Edgar Dippel
Universitätsklinikum Würzburg
Würzburg, Germany, 97080
Contact:Contact: Site Contact +49-931-201-26351 mailto:Wobser_m@ukw.de
Contact:Principal Investigator: Marion Wobser
Italy
Ospedale Maggiore Policlinico
Milan, Italy, 20122
Contact:Contact: Site Contact +39 0255033742 mailto:giorgia.saporiti@policlinico.mi.it
Contact:Principal Investigator: Giorgia Saporini
AZ OSP Citta' Della Salute (Torino)
Torino, Italy, 10126
Contact:Contact: Site Contact +39 0116335858 mailto:pietro.quaglino@unito.it
Contact:Principal Investigator: PIETRO QUAGLINO
Spain
Hospital Clinic, Barcelona
Barcelona, Spain, 08036
Contact:Contact: Site Contact +34 932 27 54 00 Ext. 2618 mailto:acombalia@clinic.cat
Contact:Principal Investigator: ANDREA COMBALIA
ICO Hospitalet, Barcelona
Barcelona, Spain, 08908
Contact:Contact: Site Contact mailto:e.gonzalez@iconcologia.net
Contact:Principal Investigator: EVA GONZALEZ BARCA
Hospital Son Espases
Palma, Spain, 07120
Contact:Contact: Site Contact +34 659882108 mailto:antoniom.gutierrez@ssib.es
Contact:Principal Investigator: Antonio Gutierrez
Open or close this module IPDSharing
Plan to Share IPD: Yes
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 Information:
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame:
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/
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services