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

Sponsor
Takeda (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03729609
Collaborator
(none)
100
Enrollment
1
Location
50
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Brentuximab vedotin (Genetical Recombination)

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 Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Drug Use Surveillance for ADCETRIS Intravenous Infusion "Untreated CD30-Positive Hodgkin's Lymphoma"
Actual Study Start Date :
Nov 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Brentuximab vedotin (Genetical Recombination)
Brentuximab vedotin Intravenous Infusion
Other Names:
  • ADCETRIS Intravenous Infusion 50 mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 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 Outcome Measures

    1. Tumor Response Rate Based on Investigator's Assessment [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Takeda Selected Site Tokyo Japan

    Sponsors and Collaborators

    • Takeda

    Investigators

    • Study Director: Study Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT03729609
    Other Study ID Numbers:
    • C25018
    • JapicCTI-184182
    First Posted:
    Nov 2, 2018
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Hodgkin Disease
    Brentuximab Vedotin

    Study Results

    No Results Posted as of Apr 5, 2022