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

Completed

• Conditions: Untreated CD30-Positive Hodgkin's Lymphoma
• Interventions: Drug: Brentuximab vedotin (Genetical Recombination)

• Registration Number: NCT03729609
• Lead Sponsor: Takeda

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-10-30
• Study Start: 2018-11-01
• Study First Submitted QC: 2018-11-01
• Study First Posted: 2018-11-02
• Primary Completion: 2023-09-27
• Study Completion: 2023-09-27
• Status Verified: 2024-03
• Results First Submitted: 2024-03-26
• Results First Submitted QC: 2024-03-26
• Last Update Submitted: 2024-03-26
• Results First Posted: 2024-08-21
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

1. Untreated participants
2. CD30-positive participants
3. Participants on concomitant Brentuximab vedotin and AVD

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Exclusion Criteria

1. Participants contraindicated for Brentuximab vedotin

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Brentuximab vedotin 1.2 mg/kg (body weight)	Brentuximab vedotin (Genetical Recombination)	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Grade 3 or Higher Neutropenia and Febrile Neutropenia	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 Outcome Measures

Name	Time	Method
Tumor Response Rate Based on Investigator's Assessment	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.

Trial Locations

Locations (1)

Takeda Selected Site; 🇯🇵 Tokyo, Japan