Clinical trial

Real-World Evidence Study on Brentuximab Vedotin Retreatment Outcomes of Cutaneous T-cell Lymphoma Patients

Name

Brentuximab-5020

Description

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.

Trial arms

Trial start

2024-02-08

Estimated PCD

2024-06-30

Trial end

2024-06-30

Status

Recruiting

Treatment

No intervention

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

Arms:

Brentuximab Vedotin

Size

Primary endpoint

Objective Response Rate (ORR) After First BV Administration

Up to approximately 12 months

ORR After Re-Treatment

Up to approximately 12 months after BV retreatment

Progression Free Survival (PFS) After First BV Administration

Up to approximately 24 months

PFS After BV Re-Treatment

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)

Up to approximately 16 months

TTNT After BV Re-Treatment

Up to approximately 24 months after BV retreatment

Number of Participant With Grading of Motor Neuropathy During First BV Treatment

Up to approximately 12 months

Time to Improvement of Motor Neuropathy During/ Post First BV Treatment

Up to approximately 24 months

Time to Resolution of Motor Neuropathy During/ Post First BV Treatment

Up to approximately 24 months

Number of Participants With Grading of Motor Neuropathy During BV Re-Treatment

Up to approximately 12 months after BV retreatment

Time to Improvement of Motor Neuropathy During/ Post BV Re-Treatment

Up to approximately 16 months

Time to Resolution of Motor Neuropathy During/ Post BV Re-Treatment

Up to approximately 24 months

Number of Participants With Grading of Sensory Neuropathy During First BV Treatment

Up to approximately 12 months

Time to Improvement of Sensory Neuropathy During/ Post First BV Treatment

Up to approximately 24 months

Time to Resolution of Sensory Neuropathy During/ Post First BV Treatment

Up to approximately 24 months

Number of Participants With Grading of Sensory Neuropathy During BV Re-Treatment

Up to approximately 12 months

Time to Improvement of Sensory Neuropathy During/ Post BV Re-Treatment

Up to approximately 24 months

Time to Resolution of Sensory Neuropathy During/ Post BV Re-Treatment

Up to approximately 24 months

Number of Participants With Grading of Neutropenia During First BV Treatment

Up to approximately 12 months

Number of Participants With Grading of Neutropenia During BV Re-Treatment

Up to approximately 12 months

Number of Participants With Grading of Febrile Neutropenia During First BV Treatment

Up to approximately 24 months

Number of Participants With Grading of Febrile Neutropenia During BV Re-Treatment

Up to approximately 12 months

Number of Participants With Grading of Serious Infections During First BV Treatment

Up to approximately 12 months

Number of Participants With Grading of Serious Infections During BV Re-Treatment

Up to approximately 12 months

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2024-03-06

1 organization

1 product

1 indication

Organization

Takeda

Product

No intervention

Indication

T-cell lymphoma