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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT05886478

Studienbeginn:
Februar 2024

Letztes Update:
06.03.2024

Wirkstoff:
No intervention

Indikation (Clinical Trials):
Lymphoma, Lymphoma, T-Cell, Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Takeda

Collaborator:
-

Studienleiter

Study Director
Study Director
Takeda

Kontakt

Studienlocations
(3 von 11)

Brustzentrum der Universitätsmedizin Göttingen
Robert-Koch-Straße 40
37075 Göttingen
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +49 551 3962005
E-Mail: mailto:christina.mitteldorf@med.uni-goettingen.de» Ansprechpartner anzeigen
Klinikum Ludwigshafen, Hautklinik
67063 Ludwigshafen
(Rheinland-Pfalz)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +496215033350
E-Mail: mailto:dippele@klilu.de» Ansprechpartner anzeigen
Onkologisches Zentrum Universitätsklinikum Würzburg
Josef-Schneider-Straße 6
97080 Würzburg
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Site Contact
Phone: +49-931-201-26351
E-Mail: mailto:Wobser_m@ukw.de» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Objective Response Rate (ORR) After First BV Administration (Time Frame - Up to approximately 12 months)

2. ORR After Re-Treatment (Time Frame - Up to approximately 12 months after BV retreatment)

3. Progression Free Survival (PFS) After First BV Administration (Time Frame - Up to approximately 24 months)

4. PFS After BV Re-Treatment (Time Frame - Up to approximately 24 months after BV retreatment)

5. 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)

6. TTNT After BV Re-Treatment (Time Frame - Up to approximately 24 months after BV retreatment)

7. Number of Participant With Grading of Motor Neuropathy During First BV Treatment (Time Frame - Up to approximately 12 months)

8. Time to Improvement of Motor Neuropathy During/ Post First BV Treatment (Time Frame - Up to approximately 24 months)

9. Time to Resolution of Motor Neuropathy During/ Post First BV Treatment (Time Frame - Up to approximately 24 months)

10. Number of Participants With Grading of Motor Neuropathy During BV Re-Treatment (Time Frame - Up to approximately 12 months after BV retreatment)

11. Time to Improvement of Motor Neuropathy During/ Post BV Re-Treatment (Time Frame - Up to approximately 16 months)

12. Time to Resolution of Motor Neuropathy During/ Post BV Re-Treatment (Time Frame - Up to approximately 24 months)

13. Number of Participants With Grading of Sensory Neuropathy During First BV Treatment (Time Frame - Up to approximately 12 months)

14. Time to Improvement of Sensory Neuropathy During/ Post First BV Treatment (Time Frame - Up to approximately 24 months)

15. Time to Resolution of Sensory Neuropathy During/ Post First BV Treatment (Time Frame - Up to approximately 24 months)

16. Number of Participants With Grading of Sensory Neuropathy During BV Re-Treatment (Time Frame - Up to approximately 12 months)

17. Time to Improvement of Sensory Neuropathy During/ Post BV Re-Treatment (Time Frame - Up to approximately 24 months)

18. Time to Resolution of Sensory Neuropathy During/ Post BV Re-Treatment (Time Frame - Up to approximately 24 months)

19. Number of Participants With Grading of Neutropenia During First BV Treatment (Time Frame - Up to approximately 12 months)

20. Number of Participants With Grading of Neutropenia During BV Re-Treatment (Time Frame - Up to approximately 12 months)

21. Number of Participants With Grading of Febrile Neutropenia During First BV Treatment (Time Frame - Up to approximately 24 months)

22. Number of Participants With Grading of Febrile Neutropenia During BV Re-Treatment (Time Frame - Up to approximately 12 months)

23. Number of Participants With Grading of Serious Infections During First BV Treatment (Time Frame - Up to approximately 12 months)

24. Number of Participants With Grading of Serious Infections During BV Re-Treatment (Time Frame - Up to approximately 12 months)

Secondary outcome:

1. Number of Participants With Cutaneous Lymphoma Co-Medications or Strategies Used to Treat CTCL Disease (Time Frame - Up to approximately 12 months)

2. Amount of BV Dose (Time Frame - Up to approximately 12 months)

3. Number of Cycles of BV Administered (Time Frame - Up to approximately 12 months)

4. Time Interval Between BV Administration (Time Frame - Up to approximately 24 months)

Geprüfte Regime

  • No intervention:
    As this is an observational study, no intervention will be administered.

Quelle: ClinicalTrials.gov


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