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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05886478
Other study ID # Brentuximab-5020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 8, 2024
Est. completion date June 30, 2024

Study information

Verified date March 2024
Source Takeda
Contact Takeda Contact
Phone +1-877-825-3327
Email medinfoUS@takeda.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
France Hopital Saint Andre Bordeaux
France Hopital Saint Louis Paris
France CHU Roeun Rouen
Germany Universitätsmedizin Göttingen Göttingen
Germany Klinikum Ludwigshafen, Hautklinik Ludwigshafen
Germany Universitätsklinikum Würzburg Würzburg
Italy Ospedale Maggiore Policlinico Milan
Italy AZ OSP Citta' Della Salute (Torino) Torino
Spain Hospital Clinic, Barcelona Barcelona
Spain ICO Hospitalet, Barcelona Barcelona
Spain Hospital Son Espases Palma

Sponsors (1)

Lead Sponsor Collaborator
Takeda

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate (ORR) After First BV Administration Up to approximately 12 months
Primary ORR After Re-Treatment Up to approximately 12 months after BV retreatment
Primary Progression Free Survival (PFS) After First BV Administration Up to approximately 24 months
Primary PFS After BV Re-Treatment Up to approximately 24 months after BV retreatment
Primary 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
Primary TTNT After BV Re-Treatment Up to approximately 24 months after BV retreatment
Primary Number of Participant With Grading of Motor Neuropathy During First BV Treatment Up to approximately 12 months
Primary Time to Improvement of Motor Neuropathy During/ Post First BV Treatment Up to approximately 24 months
Primary Time to Resolution of Motor Neuropathy During/ Post First BV Treatment Up to approximately 24 months
Primary Number of Participants With Grading of Motor Neuropathy During BV Re-Treatment Up to approximately 12 months after BV retreatment
Primary Time to Improvement of Motor Neuropathy During/ Post BV Re-Treatment Up to approximately 16 months
Primary Time to Resolution of Motor Neuropathy During/ Post BV Re-Treatment Up to approximately 24 months
Primary Number of Participants With Grading of Sensory Neuropathy During First BV Treatment Up to approximately 12 months
Primary Time to Improvement of Sensory Neuropathy During/ Post First BV Treatment Up to approximately 24 months
Primary Time to Resolution of Sensory Neuropathy During/ Post First BV Treatment Up to approximately 24 months
Primary Number of Participants With Grading of Sensory Neuropathy During BV Re-Treatment Up to approximately 12 months
Primary Time to Improvement of Sensory Neuropathy During/ Post BV Re-Treatment Up to approximately 24 months
Primary Time to Resolution of Sensory Neuropathy During/ Post BV Re-Treatment Up to approximately 24 months
Primary Number of Participants With Grading of Neutropenia During First BV Treatment Up to approximately 12 months
Primary Number of Participants With Grading of Neutropenia During BV Re-Treatment Up to approximately 12 months
Primary Number of Participants With Grading of Febrile Neutropenia During First BV Treatment Up to approximately 24 months
Primary Number of Participants With Grading of Febrile Neutropenia During BV Re-Treatment Up to approximately 12 months
Primary Number of Participants With Grading of Serious Infections During First BV Treatment Up to approximately 12 months
Primary Number of Participants With Grading of Serious Infections During BV Re-Treatment Up to approximately 12 months
Secondary Number of Participants With Cutaneous Lymphoma Co-Medications or Strategies Used to Treat CTCL Disease Up to approximately 12 months
Secondary Amount of BV Dose Up to approximately 12 months
Secondary Number of Cycles of BV Administered Up to approximately 12 months
Secondary Time Interval Between BV Administration Up to approximately 24 months
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