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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute Celgene Corporation |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00609869 |
The purpose of this research is to evaluate the use of Rituximab in combination with Revlimid in the treatment of refractory Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia (CLL). Revlimid® is a drug that changes the immune system and it may also get in the way with the growth of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Revlimid® is approved by the Food and Drug Administration (FDA) for the treatment of specific types of Myelodysplasia syndrome (MDS) and Multiple Myeloma, two different types of blood cancer.
It is currently being tested in a variety of cancer conditions. In this case it is considered experimental.
Condition | Intervention | Phase |
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Lymphocytic Leukemia Mantle Cell Lymphoma |
Drug: Lenalidomide (REVLIMID®) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Lenalidomide (REVLIMID®) in Combination With Rituximab for Patients With CD5+/CD20+ Hematologic Malignancies Who Relapse or Progress After Rituximab |
Estimated Enrollment: | 28 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Lenalidomide (REVLIMID®)
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Drug: Lenalidomide (REVLIMID®)
Lenalidomide Dose: Daily, days 1 - 21 followed by 7 days of rest in 28-day cycle
Rituximab Dose: Weekly X 4 weeks, starting on Day 15, Cycle 1
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Meet the following CLL criteria to participate in this study:
CLL Patients are eligible if they have stage III or IV disease. Patients with stage 0, I or II disease will be eligible if they have evidence of active disease defined as one or more of the following signs/symptoms:
Baseline organ and marrow function as follows:
Exclusion Criteria:
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | |
Tampa, Florida, United States, 33612 | |
Center for Cancer Care & Research/Watson | |
Lakeland, Florida, United States, 33805 |
Principal Investigator: | Javier Pinilla, M.D., PhD. | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute ( Javier Pinilla, M.D., PhD. ) |
Study ID Numbers: | MCC-14978, RV-CLL-PI-067, IRB 105338 |
Study First Received: | January 24, 2008 |
Last Updated: | February 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00609869 History of Changes |
Health Authority: | United States: Institutional Review Board |
Leukemia, Lymphoid Immunoproliferative Disorders Immunologic Factors Rituximab Lymphoma, Mantle-Cell Lenalidomide Mantle Cell Lymphoma |
Leukemia Lymphatic Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Antirheumatic Agents Lymphoma |
Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Antineoplastic Agents Rituximab Lymphoma, Mantle-Cell Physiological Effects of Drugs Lenalidomide |
Pharmacologic Actions Leukemia Lymphatic Diseases Neoplasms Therapeutic Uses Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |