Brentuximab Vedotin (Recombinant) for IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"

NCT ID: NCT02139592

Last Updated: 2020-07-13

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

292 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-17

Study Completion Date

2017-06-30

Brief Summary

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The purpose of this study is to evaluate the safety of brentuximab vedotin (recombinant) for intravenous (IV) infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma in the routine clinical setting, as well as to collect efficacy information for reference.

Detailed Description

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The present survey was designed to evaluate the safety of brentuximab vedotin (recombinant) for IV infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma in the routine clinical setting.

The usual adult dosage is 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) infused intravenously once every three weeks. The dose should be adjusted depending on the participant's condition. See the "PRECAUTIONS" section of the package insert.

Conditions

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Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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brentuximab vedotin (recombinant) Intravenous infusion

Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks

Brentuximab vedotin (recombinant)

Intervention Type DRUG

Brentuximab vedotin (recombinant) for IV infusion

Interventions

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Brentuximab vedotin (recombinant)

Brentuximab vedotin (recombinant) for IV infusion

Intervention Type DRUG

Other Intervention Names

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ADCETRIS IV Infusion 50 mg

Eligibility Criteria

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Inclusion Criteria

* All patients treated with brentuximab vedotin IV Infusion

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Osaka, , Japan

Site Status

Countries

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Japan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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JapicCTI-142455

Identifier Type: REGISTRY

Identifier Source: secondary_id

291-011

Identifier Type: -

Identifier Source: org_study_id

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