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Sponsors and Collaborators: |
Sarah Cannon Research Institute Cell Therapeutics |
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Information provided by: | Sarah Cannon Research Institute |
ClinicalTrials.gov Identifier: | NCT00193518 |
Additional active agents are needed to further improve the treatment of patients with CLL/SLL. Increasing information exists regarding the activity of arsenic trioxide in other hematologic malignancies. Since arsenic trioxide produces mild to moderate myelosuppression and is not as immunosuppressive as other available agents, it may be an additional treatment option for CLL/SLL. This study will evaluate the feasibility and toxicity of arsenic trioxide in patients with relapsed or refractory CLL/SLL
Condition | Intervention | Phase |
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Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma |
Drug: Arsenic Trioxide |
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 Trial Of Arsenic Trioxide (TRISENOX) In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be included in this study, you must meet the following criteria:
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
United States, Tennessee | |
Tennessee Oncology, PLLC | |
Nashville, Tennessee, United States, 37023 |
Principal Investigator: | John D. Hainsworth, MD | Sarah Cannon Research Institute |
Study ID Numbers: | SCRI LYM 33 |
Study First Received: | September 12, 2005 |
Last Updated: | October 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00193518 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Lymphatic Diseases Leukemia Chronic Lymphocytic Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Leukemia, Lymphocytic, Chronic, B-Cell |
Arsenic trioxide Leukemia, B-cell, Chronic Lymphoproliferative Disorders Leukemia, B-Cell Lymphoma |
Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Arsenic trioxide Pharmacologic Actions Leukemia |
Lymphatic Diseases Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Leukemia, B-Cell Lymphoproliferative Disorders Lymphoma |