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

Study Overview
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Brief Summary
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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.

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 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.

Official Title
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Drug Use Surveillance for ADCETRIS Intravenous Infusion Untreated CD30-Positive Hodgkin's Lymphoma

Conditions
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Untreated CD30-Positive Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: Brentuximab vedotin (Genetical Recombination)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Untreated participants CD30-positive participants Participants on concomitant Brentuximab vedotin and AVD Exclusion Criteria: 1. Participants contraindicated for Brentuximab vedotin
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Brentuximab vedotin 1.2 mg/kg (body weight)<br>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. | Drug: Brentuximab vedotin (Genetical Recombination)<br>* Brentuximab vedotin Intravenous Infusion<br>* Other names: ADCETRIS Intravenous Infusion 50 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Grade 3 or Higher Neutropenia and Febrile Neutropenia | Severity grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE). Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life-threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE. | Up to 2 weeks after the last dose (approximately 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Response Rate Based on Investigator's Assessment | Tumor response rate is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the Revised response criteria for malignant lymphoma by Cheson. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites. | Baseline, Up to 2 weeks after the last dose (approximately 6 months) |