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A Phase 2 Open Label Trial of SGN-35 for Systemic Anaplastic Large Cell Lymphoma - NCT00866047-10021B(Clinical Trial 542109)



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City:  New York
State:  
NY
Zip Code: 10021
Conditions: Lymphoma, Large-Cell, Anaplastic - Lymphoma, Non-Hodgkin
Purpose: 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.
Study summary:
Criteria: 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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Data Source: ClinicalTrials.gov
Date Processed: May 21, 2010
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