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| Sponsor: | Celgene Corporation |
|---|---|
| Collaborator: |
Prologue Research International |
| Information provided by: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00179673 |
Purpose
Subjects who qualify will receive lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until for up to 52 weeks or until disease progression, subjects who achieve a CR will receive an additional 2 cycles of treatment prior to discontinuation. Subjects will be followed for progression free survival following discontinuation from the treatment phase
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkins Lymphoma |
Drug: CC-5013 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin’s Lymphoma |
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | November 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any of the following laboratory abnormalities
Contacts and Locations| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, California | |
| Pacific Coast Hematology/Oncology Medical Group, Onc. | |
| Fountain Valley, California, United States, 92708 | |
| Alta Bates Cancer Center | |
| Berkeley, California, United States, 94704 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Massachusetts | |
| Harvard University | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Nebraska | |
| University of Nebraska | |
| Omaha, Nebraska, United States, 68198-6805 | |
| United States, New York | |
| New York Medical Center, MBCCOP | |
| Bronx, New York, United States, 10466 | |
| United States, Ohio | |
| Signal Point Hematology/Oncology | |
| Middletown, Ohio, United States, 45042 | |
| United States, Washington | |
| Swedish Cancer Institute | |
| Seattle, Washington, United States, 98104 | |
| United States, Wisconsin | |
| Gunderson Clinic, Ltd. | |
| La Crosse, Wisconsin, United States, 54601 | |
| Canada, British Columbia | |
| BC Community Oncology Trialist | |
| Burnaby, British Columbia, Canada, V5H 4K7 | |
| BC Community Oncology | |
| North Vancouver, British Columbia, Canada, V7L 2P9 | |
| Canada, Ontario | |
| London Regional Cancer Program | |
| London, Ontario, Canada, N6A 5W9 | |
| Canada, Saskatchewan | |
| University of Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
More Information
| Study ID Numbers: | CC-5013-NHL-001 |
| Study First Received: | September 10, 2005 |
| Last Updated: | November 30, 2006 |
| ClinicalTrials.gov Identifier: | NCT00179673 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
NHL CC5013 Non-Hodgkins Lymphoma |
revlimid cc-5013 celgene |
|
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Lenalidomide Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Pharmacologic Actions |