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

T-Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05886478
• Other study ID #: Brentuximab-5020
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Lymphoma, T-Cell, Peripheral
• T-Cell Lymphoma

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

External Links

•   To obtain more information on the study, click here/on this link