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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 February 2015 |
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Main ID: |
NCT01060904 |
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Date of registration:
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29/01/2010 |
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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 Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma
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Scientific title:
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A Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With Multi-Agent Chemotherapy as Frontline Therapy in Patients With Hodgkin Lymphoma |
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Date of first enrolment:
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January 2010 |
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Target sample size:
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51 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01060904 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Naomi Hunder, MD |
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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:
- Treatment-naive Hodgkin lymphoma, Stage IIa or IIb-IV
- Measurable disease of at least 1.5 cm
- Eastern Cooperative Oncology Group performance status <3
Exclusion Criteria:
- History of another primary malignancy that has not been in remission for at least 3
years
- Known cerebral/meningeal disease
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Disease, Hodgkin
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Intervention(s)
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Drug: bleomycin
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Drug: brentuximab vedotin
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Drug: vinblastine
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Drug: dacarbazine
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Drug: doxorubicin
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Primary Outcome(s)
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Incidence of adverse events and laboratory abnormalities
[Time Frame: Through 1 month after last dose]
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Secondary Outcome(s)
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Brentuximab vedotin concentration in blood
[Time Frame: Through 1 month after last dose]
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Antitherapeutic antibodies in blood
[Time Frame: Through 1 month after last dose]
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Best clinical response
[Time Frame: Through 1 month after last dose]
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Secondary ID(s)
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SGN35-009
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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