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

NCT ID: NCT05886478

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-08

Study Completion Date

2024-10-31

Brief Summary

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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

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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.

Conditions

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T-Cell Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No intervention

Intervention Type DRUG

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

Interventions

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No intervention

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Hopital Saint Andre

Bordeaux, , France

Site Status

Hopital Saint Louis

Paris, , France

Site Status

CHU Roeun

Rouen, , France

Site Status

Universitätsmedizin Göttingen

Göttingen, , Germany

Site Status

Klinikum Ludwigshafen, Hautklinik

Ludwigshafen, , Germany

Site Status

Universitätsklinikum Würzburg

Würzburg, , Germany

Site Status

Ospedale Maggiore Policlinico

Milan, , Italy

Site Status

AZ OSP Citta' Della Salute (Torino)

Torino, , Italy

Site Status

Hospital Clinic, Barcelona

Barcelona, , Spain

Site Status

ICO Hospitalet, Barcelona

Barcelona, , Spain

Site Status

Hospital Son Espases

Palma, , Spain

Site Status

Countries

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France Germany Italy Spain

Related Links

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Other Identifiers

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Brentuximab-5020

Identifier Type: -

Identifier Source: org_study_id