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A Survey of Brentuximab Vedotin in Pediatric Participants With Hodgkin Lymphoma

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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

Trial contacts and locations

1

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Central trial contact

Takeda Contact

Data sourced from clinicaltrials.gov

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