A Survey of Brentuximab Vedotin in Pediatric Participants With Hodgkin Lymphoma

Takeda

Status: Enrolling

Conditions: Hodgkin Lymphoma

Treatments: Drug: Brentuximab Vedotin

Study type: Observational

Funder types: Industry

Identifiers

NCT05481437

jRCT2031220244 (Registry Identifier)

Brentuximab-5019

Details and patient eligibility

About

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.

Enrollment: 8 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Treatment-naive participants
2. CD30 positive participants
3. Participants treated with the study drug in combination with doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine (AVD).
4. Participants aged < 18 years at the start of this drug.

Exclusion criteria

Participants with contraindications to the study drug.

Trial design

8 participants in 1 patient group

Brentuximab Vedotin

Description:

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

Treatment:

Drug: Brentuximab Vedotin