Trial Title:
A Study in Adults With Cutaneous T-cell Lymphoma (CTCL) Retreated With Brentuximab Vedotin
NCT ID:
NCT05886478
Condition:
T-Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Lymphoma, T-Cell, Cutaneous
Conditions: Keywords:
Drug Therapy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
No intervention
Description:
As this is an observational study, no intervention will be administered.
Arm group label:
Brentuximab Vedotin
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.
Criteria for eligibility:
Study pop:
Participants diagnosed with CTCL who were retreated with BV after relapse in France,
Germany, Spain, and Italy.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hopital Saint Andre
Address:
City:
Bordeaux
Zip:
33075
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+33 5 57 82 25 00
Email:
mailto:marie.beylot-barry@chu-bordeaux.fr
Investigator:
Last name:
Marie BEYLOT-BARRY
Email:
Principal Investigator
Facility:
Name:
Hopital Saint Louis
Address:
City:
Paris
Zip:
75010
Country:
France
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
+33 7 67 18 89 76
Email:
mailto:adele.demasson@aphp.fr
Investigator:
Last name:
Adele DE MASSON
Email:
Principal Investigator
Facility:
Name:
CHU Roeun
Address:
City:
Rouen
Zip:
76031
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+33 2 32 88 66 99
Email:
mailto:anne-benedicte.duval-modeste@chu-rouen.fr
Investigator:
Last name:
ANNE-BENEDICTE DUVAL MODESTE
Email:
Principal Investigator
Facility:
Name:
Universitätsmedizin Göttingen
Address:
City:
Göttingen
Zip:
37075
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
+49 551 3962005
Email:
mailto:christina.mitteldorf@med.uni-goettingen.de
Investigator:
Last name:
Christina Mitteldorf
Email:
Principal Investigator
Facility:
Name:
Klinikum Ludwigshafen, Hautklinik
Address:
City:
Ludwigshafen
Zip:
67063
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+496215033350
Email:
mailto:dippele@klilu.de
Investigator:
Last name:
Edgar Dippel
Email:
Principal Investigator
Facility:
Name:
Universitätsklinikum Würzburg
Address:
City:
Würzburg
Zip:
97080
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
+49-931-201-26351
Email:
mailto:Wobser_m@ukw.de
Investigator:
Last name:
Marion Wobser
Email:
Principal Investigator
Facility:
Name:
Ospedale Maggiore Policlinico
Address:
City:
Milan
Zip:
20122
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+39 0255033742
Email:
mailto:giorgia.saporiti@policlinico.mi.it
Investigator:
Last name:
Giorgia Saporini
Email:
Principal Investigator
Facility:
Name:
AZ OSP Citta' Della Salute (Torino)
Address:
City:
Torino
Zip:
10126
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+39 0116335858
Email:
mailto:pietro.quaglino@unito.it
Investigator:
Last name:
PIETRO QUAGLINO
Email:
Principal Investigator
Facility:
Name:
Hospital Clinic, Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
+34 932 27 54 00
Phone ext:
2618
Email:
mailto:acombalia@clinic.cat
Investigator:
Last name:
ANDREA COMBALIA
Email:
Principal Investigator
Facility:
Name:
ICO Hospitalet, Barcelona
Address:
City:
Barcelona
Zip:
08908
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Email:
mailto:e.gonzalez@iconcologia.net
Investigator:
Last name:
EVA GONZALEZ BARCA
Email:
Principal Investigator
Facility:
Name:
Hospital Son Espases
Address:
City:
Palma
Zip:
07120
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
+34 659882108
Email:
mailto:antoniom.gutierrez@ssib.es
Investigator:
Last name:
Antonio Gutierrez
Email:
Principal Investigator
Start date:
February 8, 2024
Completion date:
September 30, 2024
Lead sponsor:
Agency:
Takeda
Agency class:
Industry
Source:
Takeda
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05886478
https://clinicaltrials.takeda.com/study-detail/899594d64e1d4e4b?idFilter=%5B%22Brentuximab-5020%22%5D
