Completed

NCT Number: NCT03729609

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

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.

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Key information

Conditions

Untreated CD30-Positive Hodgkin's Lymphoma

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda Selected Site

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Untreated participants
CD30-positive participants
Participants on concomitant Brentuximab vedotin and AVD

Exclusion criteria

Participants contraindicated for Brentuximab vedotin

Treatment and study plan

Brentuximab vedotin (Genetical Recombination)

Drug

Brentuximab vedotin Intravenous Infusion

Other names: ADCETRIS Intravenous Infusion 50 mg

Primary outcomes

Percentage of Participants With Grade 3 or Higher Neutropenia and Febrile Neutropenia

Time frame: Up to 2 weeks after the last dose (approximately 6 months)

Severity grades was 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.

Secondary outcomes

Tumor Response Rate Based on Investigator's Assessment

Time frame: Baseline, Up to 2 weeks after the last dose (approximately 6 months)

Tumor response rate was 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2023
Study completion: 2023
First posted: Nov 2, 2018
Registry last updated: Aug 21, 2024

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.