A Phase 2 Open Label Trial of SGN-35 for Systemic Anaplastic Large Cell Lymphoma - NCT00866047-33136 (Clinical Trial 279492)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy279492.aspx
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| City: |
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Miami |
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State:
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FL |
| Zip Code: |
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33136 |
| Conditions: |
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Lymphoma, Non-Hodgkin - Lymphoma, Large-Cell, Anaplastic |
| Purpose: |
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This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and
safety of SGN-35 as a single agent in patients with relapsed or refractory ALCL.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Patients with relapsed or refractory systemic ALCL who have previously received front
line chemotherapy.
- Documented anaplastic lymphoma kinase (ALK) status.
- Histologically-confirmed CD30-positive disease; tissue from the most recent post
diagnostic biopsy of relapsed/refractory disease must be available for confirmation
of CD30 expression via slides or tumor block.
- Fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm as documented
by both PET and spiral CT.
- Received any previous ASCT at least 12 weeks (3 months) prior.
- At US sites patients greater than or equal to 12 years of age may be enrolled. At
non-US sites patients must be greater than or equal to 18 years of age.
Exclusion Criteria:
- Previous treatment with SGN-35.
- Previously received an allogeneic transplant.
- Patients with current diagnosis of primary cutaneous ALCL (patients who have
transformed to systemic ALCL are eligible).
- Known cerebral/meningeal disease. |
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| Study is available at: |
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University of Miami
Miami, FL 33136
United States
Primary Contact:
Francine Coleman
Email: fcoleman@med.miami.edu
Phone: 305-243-6823
Secondary Contact:
Terri Lowe
Email: clinicaltrials@seagen.com
Phone: 866-333-7436 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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