RecruitingNCT05481437

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)


Sponsor

Takeda

Enrollment

8 participants

Start Date

Aug 1, 2022

Study Type

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

Max Age: 18 Years

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

DRUGBrentuximab Vedotin

Brentuximab Vedotin injection, 50 mg, once every 2 weeks


Locations(1)

Takeda selected site

Tokyo, Japan

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NCT05481437


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