A Survey of Brentuximab Vedotin in Pediatric Participants With Hodgkin Lymphoma

Sponsor
Takeda
Study ID
NCT05481437
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Brentuximab Vedotin — DRUG
    Brentuximab Vedotin injection, 50 mg, once every 2 weeks

Study Details

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.

Key Dates

First listed
Aug 1, 2022
Start date
Aug 1, 2022
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
8 participants (estimated)

Arms

  • Arm: Brentuximab Vedotin
    Participants will receive Brentuximab Vedotin injection 50 mg once every 2 weeks and AVD treatment (doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine).

Primary Outcome Measure

Percentage of Participants who Experienced Myelosuppression [ Time Frame: Up to 26 Weeks ]

Central Contacts

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