Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Pediatric Hodgkin Lymphoma"

Takeda

Status: Completed

Conditions: Pediatric Hodgkin Lymphoma; Peripheral T Cell Lymphoma

Treatments: Drug: Brentuximab Vedotin (Genetical Recombination)

Study type: Observational

Funder types: Industry

Identifiers

NCT04213209

jRCT1080224999 (Registry Identifier)

C25021

Details and patient eligibility

About

The purpose of this survey is to examine the safety of adult patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (excluding anaplastic large cell lymphoma (ALCL)) and pediatric patients with relapsed or refractory CD30-positive PTCL or Hodgkin lymphoma (HL) in the actual use of on concomitant Brentuximab Vedotin 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 adult patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (excluding anaplastic large cell lymphoma (ALCL)) and pediatric patients with relapsed or refractory CD30-positive PTCL or Hodgkin lymphoma (HL).

This survey is an observational (non-interventional) study and will look at the safety of adult patients with relapsed or refractory CD30-positive PTCL (excluding ALCL) and pediatric patients with relapsed or refractory CD30-positive PTCL or HL in the routine clinical setting. The number of observed patients will be approximately 86 as total (80; Adult participants and 6; Pediatric participants).

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

Enrollment: 95 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants with relapsed or refractory lymphoma.
2. CD30-positive participants.
3. Participants who receive study drug after obtaining approval of CD30-positive PTCL indication of study drug.

Exclusion criteria

1. Participants with a history of severe hypersensitivity to Brentuximab Vedotin.
2. Participants taking bleomycin hydrochloride treatment.

Trial design

95 participants in 1 patient group

Brentuximab Vedotin 1.8 mg/kg (body weight)

Description:

The usual dosage for intravenous administration is 1.8 milligrams per kilograms (mg/kg) (body weight) as Brentuximab Vedotin (genetic recombination) once every three weeks (up to 12 months). The dose may be reduced appropriately according to the participant's condition. Participants receive interventions as part of routine medical care.

Treatment:

Drug: Brentuximab Vedotin (Genetical Recombination)