A Survey of Brentuximab Vedotin in Pediatric Participants With Hodgkin Lymphoma

Last updated: April 15, 2025
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

N/A

Condition

Marginal Zone Lymphoma

White Cell Disorders

Hematologic Cancer

Treatment

Brentuximab Vedotin

Clinical Study ID

NCT05481437
Brentuximab-5019
jRCT2031220244
  • Ages < 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Treatment-naive participants

  2. CD30 positive participants

  3. Participants treated with the study drug in combination with doxorubicinhydrochloride, vinblastine sulfate, and dacarbazine (AVD).

  4. Participants aged < 18 years at the start of this drug.

Exclusion

Exclusion Criteria:

Participants with contraindications to the study drug.

Study Design

Total Participants: 8
Treatment Group(s): 1
Primary Treatment: Brentuximab Vedotin
Phase:
Study Start date:
August 01, 2022
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • Takeda selected site

    Tokyo,
    Japan

    Active - Recruiting

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