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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-14

Study Completion Date

2023-12-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral T Cell Lymphoma Pediatric Hodgkin Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Brentuximab Vedotin 1.8 mg/kg (body weight)

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.

Brentuximab Vedotin (Genetical Recombination)

Intervention Type DRUG

Brentuximab Vedotin Intravenous Infusion

Interventions

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Brentuximab Vedotin (Genetical Recombination)

Brentuximab Vedotin Intravenous Infusion

Intervention Type DRUG

Other Intervention Names

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ADCETRIS Intravenous Infusion 50 mg

Eligibility Criteria

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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.