Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion “Untreated CD30-Positive Hodgkin’s Lymphoma”

Overview

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.

Full Title of Study: “Drug Use Surveillance for ADCETRIS Intravenous Infusion “Untreated CD30-Positive Hodgkin’s Lymphoma”"

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 31, 2022

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.

Interventions

  • Drug: Brentuximab vedotin (Genetical Recombination)
    • Brentuximab vedotin Intravenous Infusion

Arms, Groups and Cohorts

  • Brentuximab vedotin 1.2 mg/kg (body weight)
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 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.

Secondary Measures

  • 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 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.

Participating in This Clinical Trial

Inclusion Criteria

1. Untreated participants

2. CD30-positive participants

3. Participants on concomitant Brentuximab vedotin and AVD

Exclusion Criteria

1. Participants contraindicated for Brentuximab vedotin

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Takeda
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Study Director, Takeda
  • Overall Contact(s)
    • Takeda Study Registration Call Center, +1-877-825-3327, medicalinformation@tpna.com

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