A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma
This study is ongoing, but not recruiting participants.
Sponsor:
Seattle Genetics, Inc.
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00866047
First received: March 19, 2009
Last updated: November 10, 2011
Last verified: November 2011
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Tracking Information | |||||
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First Received Date ICMJE | March 19, 2009 | ||||
Last Updated Date | November 10, 2011 | ||||
Start Date ICMJE | March 2009 | ||||
Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Objective Response Rate by Independent Review Group [ Time Frame: up to 12 months ] [ Designated as safety issue: No ] Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. |
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Original Primary Outcome Measures ICMJE |
Best clinical response [ Time Frame: Every 2 to 3 months ] [ Designated as safety issue: No ] | ||||
Change History | Complete list of historical versions of study NCT00866047 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma | ||||
Official Title ICMJE | A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL) | ||||
Brief Summary | This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Names:
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Study Arm (s) | Experimental: Brentuximab vedotin
Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Intervention: Drug: brentuximab vedotin |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Enrollment ICMJE | 58 | ||||
Estimated Completion Date | June 2016 | ||||
Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 12 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States, Belgium, Canada, France, United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00866047 | ||||
Other Study ID Numbers ICMJE | SG035-0004, 2008-006035-12 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Seattle Genetics, Inc. | ||||
Study Sponsor ICMJE | Seattle Genetics, Inc. | ||||
Collaborators ICMJE | Millennium Pharmaceuticals, Inc. | ||||
Investigators ICMJE |
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Information Provided By | Seattle Genetics, Inc. | ||||
Verification Date | November 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |