Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Untreated CD30-Positive Hodgkin's Lymphoma"
NCT ID: NCT03729609
Last Updated: 2024-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
113 participants
OBSERVATIONAL
2018-11-01
2023-09-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Brentuximab vedotin (Genetical Recombination)
Brentuximab vedotin Intravenous Infusion
Interventions
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Brentuximab vedotin (Genetical Recombination)
Brentuximab vedotin Intravenous Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. CD30-positive participants
3. Participants on concomitant Brentuximab vedotin and AVD
Exclusion Criteria
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Takeda Selected Site
Tokyo, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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jRCT1080224121
Identifier Type: REGISTRY
Identifier Source: secondary_id
C25018
Identifier Type: -
Identifier Source: org_study_id
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