T-Cell LymphomaNCT05886478
A Study in Adults With Cutaneous T-cell Lymphoma (CTCL) Retreated With Brentuximab Vedotin
An observational study of T-Cell Lymphoma, run by Takeda at 11 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T-Cell Lymphoma
- How many people
- 26 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 8 Feb 2024to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants diagnosed with CTCL who were retreated with BV after relapse in France, Germany, Spain, and Italy.
Who may be able to join
- 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
Who cannot join
- There are no exclusion criteria for this study.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
France3 sites
Hopital Saint Andre
Bordeaux, 33075
Hopital Saint Louis
Paris, 75010
CHU Roeun
Rouen, 76031
Germany3 sites
Universitätsmedizin Göttingen
Göttingen, 37075
Klinikum Ludwigshafen, Hautklinik
Ludwigshafen, 67063
Universitätsklinikum Würzburg
Würzburg, 97080
Spain3 sites
Hospital Clinic, Barcelona
Barcelona, 08036
ICO Hospitalet, Barcelona
Barcelona, 08908
Hospital Son Espases
Palma, 07120
Italy2 sites
Ospedale Maggiore Policlinico
Milan, 20122
AZ OSP Citta' Della Salute (Torino)
Torino, 10126
About this study
Official title: Real-World Evidence Study on Brentuximab Vedotin Retreatment Outcomes of Cutaneous T-cell Lymphoma Patients
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.
Read the 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.
- Conditions
- T-Cell Lymphoma
- Being tested
- No intervention
- Keywords
- Drug Therapy
- Medical subject headings
- Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDrug
As this is an observational study, no intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Brentuximab Vedotin | Participants with CTCL who were retreated with BV after relapse will be observed retrospectively and the outcomes will be observed from June 2023 to September 2023. Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) After First BV Administration
Measured: Up to approximately 12 months
ORR After Re-Treatment
Measured: Up to approximately 12 months after BV retreatment
Progression Free Survival (PFS) After First BV Administration
Measured: Up to approximately 24 months
PFS After BV Re-Treatment
Measured: 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)
Measured: Up to approximately 16 months
TTNT After BV Re-Treatment
Measured: Up to approximately 24 months after BV retreatment
Number of Participant With Grading of Motor Neuropathy During First BV Treatment
Measured: Up to approximately 12 months
Time to Improvement of Motor Neuropathy During/ Post First BV Treatment
Measured: Up to approximately 24 months
Time to Resolution of Motor Neuropathy During/ Post First BV Treatment
Measured: Up to approximately 24 months
Number of Participants With Grading of Motor Neuropathy During BV Re-Treatment
Measured: Up to approximately 12 months after BV retreatment
Time to Improvement of Motor Neuropathy During/ Post BV Re-Treatment
Measured: Up to approximately 16 months
Time to Resolution of Motor Neuropathy During/ Post BV Re-Treatment
Measured: Up to approximately 24 months
Number of Participants With Grading of Sensory Neuropathy During First BV Treatment
Measured: Up to approximately 12 months
Time to Improvement of Sensory Neuropathy During/ Post First BV Treatment
Measured: Up to approximately 24 months
Time to Resolution of Sensory Neuropathy During/ Post First BV Treatment
Measured: Up to approximately 24 months
Number of Participants With Grading of Sensory Neuropathy During BV Re-Treatment
Measured: Up to approximately 12 months
Time to Improvement of Sensory Neuropathy During/ Post BV Re-Treatment
Measured: Up to approximately 24 months
Time to Resolution of Sensory Neuropathy During/ Post BV Re-Treatment
Measured: Up to approximately 24 months
Number of Participants With Grading of Neutropenia During First BV Treatment
Measured: Up to approximately 12 months
Number of Participants With Grading of Neutropenia During BV Re-Treatment
Measured: Up to approximately 12 months
Number of Participants With Grading of Febrile Neutropenia During First BV Treatment
Measured: Up to approximately 24 months
Number of Participants With Grading of Febrile Neutropenia During BV Re-Treatment
Measured: Up to approximately 12 months
Number of Participants With Grading of Serious Infections During First BV Treatment
Measured: Up to approximately 12 months
Number of Participants With Grading of Serious Infections During BV Re-Treatment
Measured: Up to approximately 12 months
Secondary outcomes (4)
Number of Participants With Cutaneous Lymphoma Co-Medications or Strategies Used to Treat CTCL Disease
Measured: Up to approximately 12 months
Amount of BV Dose
Measured: Up to approximately 12 months
Number of Cycles of BV Administered
Measured: Up to approximately 12 months
Time Interval Between BV Administration
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start8 Feb 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886478
- Sponsor's protocol ID
- Brentuximab-5020
- Status last verified
- Dec 2024
- First submitted
- 24 May 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Evidence Study on Brentuximab Vedotin Retreatment Outcomes of Cutaneous T-cell Lymphoma Patients
- ClinicalTrials.gov ID
- NCT05886478
- Acronym / sponsor ID
- Brentuximab-5020
- Conditions
- T-Cell Lymphoma
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brentuximab Vedotin | – | Drug: No interventionParticipants with CTCL who were retreated with BV after relapse will be observed retrospectively and the outcomes will be observed from June 2023 to September 2023. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with CTCL who were retreated with BV after relapse in France, Germany, Spain, and Italy.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionAs this is an observational study, no intervention will be administered. | Drug | Brentuximab Vedotin |
Primary outcome
Objective Response Rate (ORR) After First BV Administration
Time frame: Up to approximately 12 months
ORR After Re-Treatment
Time frame: Up to approximately 12 months after BV retreatment
Progression Free Survival (PFS) After First BV Administration
Time frame: Up to approximately 24 months
PFS After BV Re-Treatment
Time frame: 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)
Time frame: Up to approximately 16 months
TTNT After BV Re-Treatment
Time frame: Up to approximately 24 months after BV retreatment
Number of Participant With Grading of Motor Neuropathy During First BV Treatment
Time frame: Up to approximately 12 months
Time to Improvement of Motor Neuropathy During/ Post First BV Treatment
Time frame: Up to approximately 24 months
Time to Resolution of Motor Neuropathy During/ Post First BV Treatment
Time frame: Up to approximately 24 months
Number of Participants With Grading of Motor Neuropathy During BV Re-Treatment
Time frame: Up to approximately 12 months after BV retreatment
Time to Improvement of Motor Neuropathy During/ Post BV Re-Treatment
Time frame: Up to approximately 16 months
Time to Resolution of Motor Neuropathy During/ Post BV Re-Treatment
Time frame: Up to approximately 24 months
Number of Participants With Grading of Sensory Neuropathy During First BV Treatment
Time frame: Up to approximately 12 months
Time to Improvement of Sensory Neuropathy During/ Post First BV Treatment
Time frame: Up to approximately 24 months
Time to Resolution of Sensory Neuropathy During/ Post First BV Treatment
Time frame: Up to approximately 24 months
Number of Participants With Grading of Sensory Neuropathy During BV Re-Treatment
Time frame: Up to approximately 12 months
Time to Improvement of Sensory Neuropathy During/ Post BV Re-Treatment
Time frame: Up to approximately 24 months
Time to Resolution of Sensory Neuropathy During/ Post BV Re-Treatment
Time frame: Up to approximately 24 months
Number of Participants With Grading of Neutropenia During First BV Treatment
Time frame: Up to approximately 12 months
Number of Participants With Grading of Neutropenia During BV Re-Treatment
Time frame: Up to approximately 12 months
Number of Participants With Grading of Febrile Neutropenia During First BV Treatment
Time frame: Up to approximately 24 months
Number of Participants With Grading of Febrile Neutropenia During BV Re-Treatment
Time frame: Up to approximately 12 months
Number of Participants With Grading of Serious Infections During First BV Treatment
Time frame: Up to approximately 12 months
Number of Participants With Grading of Serious Infections During BV Re-Treatment
Time frame: Up to approximately 12 months
4 secondary outcomes
Number of Participants With Cutaneous Lymphoma Co-Medications or Strategies Used to Treat CTCL Disease
Time frame: Up to approximately 12 months
Amount of BV Dose
Time frame: Up to approximately 12 months
Number of Cycles of BV Administered
Time frame: Up to approximately 12 months
Time Interval Between BV Administration
Time frame: Up to approximately 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of T-Cell Lymphoma, run by Takeda at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Germany, Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) After First BV Administration (time frame: Up to approximately 12 months). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.