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"

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.

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Key information

Conditions

Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Sex eligibility

All sexes

Study type

Observational

Primary location

Osaka, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients treated with brentuximab vedotin IV Infusion

Exclusion criteria

None

Treatment and study plan

Brentuximab vedotin (recombinant)

Drug

Brentuximab vedotin (recombinant) for IV infusion

Other names: ADCETRIS IV Infusion 50 mg

Primary outcomes

Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)

Time frame: Up to Week 48 or until discontinuation of treatment

Secondary outcomes

Percentage of Participants Who Achieve or Maintain Any Best Response

Time frame: Up to Week 48 or until discontinuation of treatment

Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), complete response uncertain (CRu) (when no positron emission tomography [PET] data are available), and complete response (CR) after each cycle of treatment. Reported data are divided into 4 populations; Hodgkin's lymphoma (HL) participants with PET data, HL participants without PET data, anaplastic large cell lymphoma (ALCL) participants with PET data, and ALCL participants without PET data. PET is used in cancer diagnosis and treatment.
Overall Survival (OS)

Time frame: Up to Week 48 or until discontinuation of treatment

OS is defined as the period from the start of therapy in standard medical care to the time when death (regardless of the cause of death) is confirmed. Reported data as OS was point estimates of 1 year survival rate for HL and ALCL participants.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: May 15, 2014
Registry last updated: Jul 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed