Clinical trial NCT05886478: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: T-Cell Lymphoma
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2023-06-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants diagnosed with CTCL who were retreated with BV after relapse in France, Germany, Spain, and Italy.

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.

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.

Primary outcomes:
measure: Objective Response Rate (ORR) After First BV Administration
timeFrame: Up to approximately 12 months
measure: ORR After Re-Treatment
timeFrame: Up to approximately 12 months after BV retreatment
measure: Progression Free Survival (PFS) After First BV Administration
timeFrame: Up to approximately 24 months
measure: PFS After BV Re-Treatment
timeFrame: Up to approximately 24 months after BV retreatment
measure: Time to Next Treatment (TTNT) After First BV Administration (Regardless of Type of Next Treatment, i.e., BV or non-BV)
timeFrame: Up to approximately 16 months
measure: TTNT After BV Re-Treatment
timeFrame: Up to approximately 24 months after BV retreatment
measure: Number of Participant With Grading of Motor Neuropathy During First BV Treatment
timeFrame: Up to approximately 12 months
measure: Time to Improvement of Motor Neuropathy During/ Post First BV Treatment
timeFrame: Up to approximately 24 months
measure: Time to Resolution of Motor Neuropathy During/ Post First BV Treatment
timeFrame: Up to approximately 24 months
measure: Number of Participants With Grading of Motor Neuropathy During BV Re-Treatment
timeFrame: Up to approximately 12 months after BV retreatment
measure: Time to Improvement of Motor Neuropathy During/ Post BV Re-Treatment
timeFrame: Up to approximately 16 months
measure: Time to Resolution of Motor Neuropathy During/ Post BV Re-Treatment
timeFrame: Up to approximately 24 months
measure: Number of Participants With Grading of Sensory Neuropathy During First BV Treatment
timeFrame: Up to approximately 12 months
measure: Time to Improvement of Sensory Neuropathy During/ Post First BV Treatment
timeFrame: Up to approximately 24 months
measure: Time to Resolution of Sensory Neuropathy During/ Post First BV Treatment
timeFrame: Up to approximately 24 months
measure: Number of Participants With Grading of Sensory Neuropathy During BV Re-Treatment
timeFrame: Up to approximately 12 months
measure: Time to Improvement of Sensory Neuropathy During/ Post BV Re-Treatment
timeFrame: Up to approximately 24 months
measure: Time to Resolution of Sensory Neuropathy During/ Post BV Re-Treatment
timeFrame: Up to approximately 24 months
measure: Number of Participants With Grading of Neutropenia During First BV Treatment
timeFrame: Up to approximately 12 months
measure: Number of Participants With Grading of Neutropenia During BV Re-Treatment
timeFrame: Up to approximately 12 months
measure: Number of Participants With Grading of Febrile Neutropenia During First BV Treatment
timeFrame: Up to approximately 24 months
measure: Number of Participants With Grading of Febrile Neutropenia During BV Re-Treatment
timeFrame: Up to approximately 12 months
measure: Number of Participants With Grading of Serious Infections During First BV Treatment
timeFrame: Up to approximately 12 months
measure: Number of Participants With Grading of Serious Infections During BV Re-Treatment
timeFrame: Up to approximately 12 months
Secondary outcomes:
measure: Number of Participants With Cutaneous Lymphoma Co-Medications or Strategies Used to Treat CTCL Disease
timeFrame: Up to approximately 12 months
measure: Amount of BV Dose
timeFrame: Up to approximately 12 months
measure: Number of Cycles of BV Administered
timeFrame: Up to approximately 12 months
measure: Time Interval Between BV Administration
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Paris
country: France
facility: Hopital Saint Louis
city: Rouen
country: France
facility: CHU Roeun
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen, Hautklinik
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Milan
country: Italy
facility: Ospedale Maggiore Policlinico
city: Torino
country: Italy
facility: AZ OSP Citta' Della Salute (Torino)
city: Barcelona
country: Spain
facility: Hospital Clinic, Barcelona
city: Barcelona
country: Spain
facility: ICO Hospitalet, Barcelona
city: Palma
country: Spain
facility: Hospital Son Espases
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: