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| Sponsored by: |
Eisai Medical Research Inc. |
|---|---|
| Information provided by: | Eisai Medical Research Inc. |
| ClinicalTrials.gov Identifier: | NCT00051025 |
Purpose
The purpose of this study is to look at the safety and effectiveness of ONTAK in previously treated patients with NHL.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma Lymphoma, B-Cell Lymphoma, Low-Grade |
Drug: ONTAK |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Multicenter, Phase II Evaluation of ONTAK (Denileukin Diftitox) in Patients With Previously Treated, Indolent, B-Cell, Non-Hodgkin's Lymphoma |
| Estimated Enrollment: | 64 |
| Study Start Date: | May 2000 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | January 2001 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Acceptable organ function defined as follows:
Female patients must meet the following criteria:
Exclusion Criteria:
Contacts and Locations| United States, Kentucky | |
| Central Baptist Hospital | |
| Lexington, Kentucky, United States, 40503 | |
| United States, Louisiana | |
| Hematology and Oncology Services | |
| Metairie, Louisiana, United States, 70006 | |
| Study Director: | Elyane Lombardy, M.D. | Ligand Pharmaceuticals |
More Information
| Study ID Numbers: | L4389-30 |
| Study First Received: | December 31, 2002 |
| Last Updated: | April 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00051025 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell Lymphatic Diseases Immunoproliferative Disorders B-cell Lymphomas |
Denileukin diftitox Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Pharmacologic Actions Lymphoma, B-Cell Lymphatic Diseases |
Neoplasms Denileukin diftitox Therapeutic Uses Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |