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Sponsors and Collaborators: |
Genentech Seattle Genentics |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00556699 |
This is an open-label, multicenter Phase Ib study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of SGN-40 when combined with rituximab in patients with relapsed CD20-positive, follicular or marginal zone NHL who have received at least one prior rituximab-containing regimen.
Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma |
Drug: SGN-40 Drug: rituximab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | An Open-Label, Phase Ib Study of the Safety, Pharmacokinetics, and Activity of the Anti-CD40 Monoclonal Antibody SGN-40 Administered in Combination With Rituximab in Patients With CD20-Positive, Follicular and Marginal Zone B-Cell Non-Hodgkin's Lymphoma Who Have Relapsed Following Previous Rituximab Therapy |
Estimated Enrollment: | 38 |
Study Start Date: | December 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Nevada | |
Nevada Cancer Institute | Recruiting |
Las Vegas, Nevada, United States, 89135 | |
Contact: Christine Zades 702-822-5433 czades@nvcancer.org | |
United States, New Jersey | |
Hackensack Univ Medical Center | Recruiting |
Hackensack, New Jersey, United States, 07601 | |
Contact: Peggy Ford 201-336-8612 pford@humed.com | |
United States, South Carolina | |
Cancer Ctrs of the Carolina | Recruiting |
Greenville, South Carolina, United States, 29605 | |
Contact: Lisa Johnson 864-679-3964 lisa.johnson@usoncology.com |
Study Director: | Deborah Hurst, M.D. | Genentech |
Responsible Party: | Genentech, Inc. |
Study ID Numbers: | ACF4325g |
Study First Received: | November 9, 2007 |
Last Updated: | March 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00556699 |
Health Authority: | United States: Food and Drug Administration |
NHL Rituxan anti-CD40 |
NHL Rituxan anti-CD40 |
Antibodies, Monoclonal Lymphoma, B-Cell Lymphatic Diseases Antibodies Immunoproliferative Disorders Rituximab |
B-cell lymphomas Lymphoma, small cleaved-cell, diffuse Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |