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

Untreated CD30-Positive Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03729609
• Other study ID #: C25018
• Secondary ID: jRCT1080224121
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: September 27, 2023

Study information

• Verified date: January 2024
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: September 27, 2023
• Est. primary completion date: September 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Untreated CD30-Positive Hodgkin's Lymphoma

Intervention

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

Locations

Country	Name	City	State
Japan	Takeda Selected Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)

External Links

•   To obtain more information on the study, click here/on this link