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Sponsored by: |
Seattle Genetics, Inc. |
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Information provided by: | Seattle Genetics, Inc. |
ClinicalTrials.gov Identifier: | NCT00848926 |
This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of SGN-35 as a single agent in patients with relapsed or refractory Hodgkin lymphoma.
Condition | Intervention | Phase |
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Disease, Hodgkin |
Drug: SGN-35 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin's Lymphoma (HL) |
Estimated Enrollment: | 100 |
Study Start Date: | February 2009 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: SGN-35
Every 21 days by IV infusion (1.8 mg/kg)
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Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Eric Sievers, MD | Seattle Genetics, Inc. |
Responsible Party: | Seattle Genetics ( Eric Sievers, MD ) |
Study ID Numbers: | SG035-0003 |
Study First Received: | February 18, 2009 |
Last Updated: | August 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00848926 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antigens, CD30 Antibody-Drug Conjugate Antibodies, Monoclonal Disease, Hodgkin Hematologic Diseases |
Lymphoma monomethylauristatin E Drug Therapy Immunotherapy |
Antibodies, Monoclonal Lymphatic Diseases Antibodies Immunoproliferative Disorders Hodgkin Lymphoma, Adult Hematologic Diseases |
Hodgkin's Disease Lymphoproliferative Disorders Hodgkin Disease Lymphoma Immunoglobulins |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma Hodgkin Disease |