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Sponsors and Collaborators: |
Genentech Amgen |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00400764 |
This Phase Ib/II, open-label, multicenter trial is designed to evaluate the safety, pharmacokinetics, and efficacy of Apo2L/TRAIL when combined with rituximab in subjects with follicular, CD20+, B-cell NHL that has progressed following a response of ≥ 6 months duration to a prior rituximab-containing therapy. The multicenter, international, randomized Phase II part of this study will commence only after the safety and available pharmacokinetic data from the Phase Ib part of the study have been evaluated by the Sponsor and have been provided to participating investigators and the FDA.
At this point in time, the Phase Ib portion of the study is complete and the Phase II portion of the study is active.
Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma |
Drug: APO2L/TRAIL Drug: rituximab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | A Phase Ib/II, Open-Label, Multicenter Study of the Safety, Pharmacokinetics, and Efficacy of APO2L/TRAIL Administered Intravenously in Combination With Rituximab to Subjects With Follicular and Other Low-Grade, CD20+, B-Cell Non-Hodgkin's Lymphomas That Have Progressed Following Previous Rituximab Therapy |
Estimated Enrollment: | 132 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator |
Drug: rituximab
Intravenous repeating dose
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2: Experimental |
Drug: APO2L/TRAIL
Intravenous repeating dose
Drug: rituximab
Intravenous repeating dose
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3: Experimental |
Drug: APO2L/TRAIL
Intravenous repeating dose
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
Study ID Numbers: | APO3585g |
Study First Received: | November 15, 2006 |
Last Updated: | June 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00400764 History of Changes |
Health Authority: | United States: Food and Drug Administration |
NHL Follicular NHL Rituxan |
Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell Lymphatic Diseases Immunoproliferative Disorders Immunologic Factors B-cell Lymphomas |
Rituximab Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs Pharmacologic Actions |
Lymphatic Diseases Neoplasms Therapeutic Uses Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Antirheumatic Agents Lymphoma |