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Sponsors and Collaborators: |
Massachusetts General Hospital Beth Israel Deaconess Medical Center Novartis |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00869999 |
Everolimus is an oral mTOR inhibitor with demonstrated preliminary efficacy and safety in diffuse large B-cell lymphoma (DLBCL) in both preclinical and clinical studies. The purpose of this research study is to determine whether Everolimus plus rituximab is safe and effective in participants with relapsed or refractory DLBCL. Everolimus is an investigational drug that works by blocking a special protein that helps cancer cells grow. The safety and effectiveness of Everolimus in the treatment of DLBCL has not yet been fully determined and is still investigational. The other drug in this study, rituximab, is approved by the US Food and Drug Administration (FDA) for use in patients who have diffuse large B-cell lymphoma and certain other types of non-Hodgkin lymphoma. Rituximab is a drug that destroys both normal and cancerous B-cells.
Condition | Intervention | Phase |
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Diffuse Large B-Cell Lymphoma |
Drug: Everolimus Drug: rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Everolimus in Combination With Rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma |
Estimated Enrollment: | 25 |
Study Start Date: | May 2009 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Participants will receive oral Everolimus and intravenous rituximab for DLBCL that has relapsed or been refractory to prior therapy.
Responding subjects may receive up to 6 cycles of Everolimus plus rituximab, and an additional 6 months of oral Everolimus for participants continuing to respond.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients with prostate cancer are allowed if PSA is less than 1
Contact: Jeremy S. Abramson, MD | 617-726-8743 | jabramson@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Kathleen Shea 617-724-9190 kshea@partners.org | |
Contact: Christine Connolly 617-726-5131 cconnolly1@partners.org | |
Principal Investigator: Jeremy S. Abramson, MD | |
Beth Israel Deaconsess Medical Center | Not yet recruiting |
Boston, Massachusetts, United States, 02215 | |
Principal Investigator: Robin Joyce, MD |
Principal Investigator: | Jeremy S. Abramson, MD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Jeremy S. Abramson, MD ) |
Study ID Numbers: | 09-002 |
Study First Received: | March 25, 2009 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00869999 History of Changes |
Health Authority: | United States: Food and Drug Administration |
rituximab everolimus DLBCL mTOR |
Everolimus Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Immunologic Factors Rituximab Immunosuppressive Agents Lymphoma, B-Cell |
Lymphatic Diseases B-cell Lymphomas Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma, Large-cell Antirheumatic Agents Lymphoma |
Everolimus Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Lymphoma, B-Cell Lymphatic Diseases Neoplasms Therapeutic Uses Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |