A Survey of Brentuximab Vedotin in Pediatric Participants With Hodgkin Lymphoma
Specified Drug Use Surveillance for ADCETRIS Intravenous Infusion 50 mg -Untreated CD30 Positive Hodgkin Lymphoma (Pediatric)
Takeda
8 participants
Aug 1, 2022
OBSERVATIONAL
Conditions
Summary
This study is a survey in Japan of Brentuximab Vedotin used to treat children or teenagers with Hodgkin lymphoma (HL). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects related from Brentuximab Vedotin especially myelosupression, peripheral neuropathy, and lung disorder. During the study, pediatric participants with HL will take Brentuximab Vedotin injection and AVD treatment (doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine) according to their clinic's standard practice. The study doctors will check for side effects from Brentuximab Vedotin for 26 weeks.
Eligibility
Inclusion Criteria4
- Treatment-naive participants
- CD30 positive participants
- Participants treated with the study drug in combination with doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine (AVD).
- Participants aged \< 18 years at the start of this drug.
Exclusion Criteria1
- Participants with contraindications to the study drug.
Interventions
Brentuximab Vedotin injection, 50 mg, once every 2 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05481437