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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Drug | As this is an observational study, no intervention will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cutaneous Lymphoma Co-Medications or Strategies Used to Treat CTCL Disease | Up to approximately 12 months | |
| Amount of BV Dose | Up to approximately 12 months | |
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Inclusion criteria:
Exclusion criteria:
There are no exclusion criteria for this study.
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Participants diagnosed with CTCL who were retreated with BV after relapse in France, Germany, Spain, and Italy.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Saint Andre | Bordeaux | 33075 | France | |||
| Hopital Saint Louis |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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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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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 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 |
| Number of Cycles of BV Administered |
| Up to approximately 12 months |
| Time Interval Between BV Administration | Up to approximately 24 months |
| Paris |
| 75010 |
| France |
| CHU Roeun | Rouen | 76031 | France |
| Universitätsmedizin Göttingen | Göttingen | 37075 | Germany |
| Klinikum Ludwigshafen, Hautklinik | Ludwigshafen | 67063 | Germany |
| Universitätsklinikum Würzburg | Würzburg | 97080 | Germany |
| Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| AZ OSP Citta' Della Salute (Torino) | Torino | 10126 | Italy |
| Hospital Clinic, Barcelona | Barcelona | 08036 | Spain |
| ICO Hospitalet, Barcelona | Barcelona | 08908 | Spain |
| Hospital Son Espases | Palma | 07120 | Spain |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |