Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Untreated CD30-Positive Hodgkin's Lymphoma"

Takeda

Status: Completed

Conditions: Untreated CD30-Positive Hodgkin's Lymphoma

Treatments: Drug: Brentuximab vedotin (Genetical Recombination)

Study type: Observational

Funder types: Industry

Identifiers

NCT03729609

jRCT1080224121 (Registry Identifier)

C25018

Details and patient eligibility

About

The purpose of this survey is to monitor and identify the occurrence of neutropenia and febrile neutropenia in untreated CD30-positive Hodgkin's lymphoma participants on concomitant brentuximab vedotin and doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine (AVD) in routine clinical practice.

Full description

The drug being tested in this survey is called brentuximab vedotin intravenous infusion 50 mg. This intravenous infusion is being tested to treat people with untreated CD30-positive Hodgkin's lymphoma.

This survey is an observational (non-interventional) study and will look at the occurrence of neutropenia and febrile neutropenia in untreated CD30-positive Hodgkin's lymphoma patients on concomitant brentuximab vedotin and AVD in the routine clinical setting. The planned number of observed patients will be approximately 100.

This multi-center observational trial will be conducted in Japan.

Enrollment: 113 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Untreated participants
2. CD30-positive participants
3. Participants on concomitant Brentuximab vedotin and AVD

Exclusion criteria

1. Participants contraindicated for Brentuximab vedotin

Trial design

113 participants in 1 patient group

Brentuximab vedotin 1.2 mg/kg (body weight)

Description:

Brentuximab vedotin 1.2 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every two weeks (up to 12 times). The dose should be adjusted depend on the participant's condition. Participants received interventions as part of routine medical care.

Treatment:

Drug: Brentuximab vedotin (Genetical Recombination)