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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00947856 |
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Date of registration:
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24/07/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study
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Scientific title:
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Treatment With SGN-35 in Patients With CD30-positive Hematologic Malignancies Who Have Previously Participated in an SGN-35 Study |
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Date of first enrolment:
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July 2009 |
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Target sample size:
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110 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00947856 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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France
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United States
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Contacts
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Name:
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Laurie Grove, PA-C |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seattle Genetics, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Participated in a previous brentuximab vedotin study.
- CD30-positive hematologic malignancy.
- At a minimum, experienced clinical benefit in the prior brentuximab vedotin study. For
retreatment, patients must have previously achieved either complete or partial
remission with brentuximab vedotin and experienced disease progression after
discontinuing the prior brentuximab vedotin study.
Exclusion Criteria:
Withdrew consent to participate in any prior brentuximab vedotin study.
Age minimum:
6 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lymphoma, Large-Cell, Anaplastic
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Lymphoma, Non-Hodgkin
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Disease, Hodgkin
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Intervention(s)
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Drug: brentuximab vedotin
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Primary Outcome(s)
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Adverse Events by Severity, Seriousness, and Relationship to Treatment
[Time Frame: up to 39 months]
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Laboratory Abnormalities >/= Grade 3
[Time Frame: Up to 39 months]
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Objective Response Rate by Investigator
[Time Frame: Up to approximately 38 months]
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Secondary Outcome(s)
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Overall Survival
[Time Frame: Up to approximately 41 months]
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Progression-free Survival by Kaplan-Meier Analysis
[Time Frame: Up to approximately 29 months]
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Incidence of Antitherapeutic Antibodies
[Time Frame: Up to 39 months]
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Duration of Objective Response by Kaplan-Meier Analysis
[Time Frame: Up to 38 months]
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Secondary ID(s)
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2010-019932-11
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SGN35-006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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