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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00694590 |
The purpose of this research study is to determine if AMD3100 can release CLL/SLL cells into the blood and make them more sensitive to killing by rituximab, an anti-cancer drug that is commonly used in treating CLL and SLL. In this study, AMD3100 will be added to standard treatment with rituximab. Subjects will be monitored to see how well they tolerate the use of these drugs together and how well they work to treat the leukemia.
The study is divided into Part 1 and Part 2. The purpose of Part 1 of the study is to find the highest dose of AMD3100 used with rituximab that can be given safely. The purpose of Part 2 of the study is to find out what effects (good and bad) that AMD3100, when used with rituximab, has on the subject and his/her leukemia.
Condition | Intervention | Phase |
---|---|---|
Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma (SLL) |
Drug: Plerixafor |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of AMD3100 and Rituximab in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
Estimated Enrollment: | 49 |
Study Start Date: | April 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: Plerixafor |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Medical Information | 800-745-4447 | medinfo@genzyme.com |
Contact: Medical Information | 617-252-7832 | medinfo@genzyme.com |
United States, Ohio | |
Ohio State University Comprehensive Cancer Center | Recruiting |
Columbus, Ohio, United States | |
Contact: Thomas Lin, MD | |
Contact: John C Byrd, MD | |
Principal Investigator: Thomas Lin, MD | |
Sub-Investigator: John C Byrd, MD |
Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
Study ID Numbers: | MOZO00207 |
Study First Received: | June 6, 2008 |
Last Updated: | June 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00694590 |
Health Authority: | United States: Food and Drug Administration |
AMD3100 Rituximab Chronic Lymphocytic Leukemia |
CLL Small Lymphocytic Lymphoma SLL |
Chronic lymphocytic leukemia Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Rituximab |
JM 3100 Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, chronic Lymphoproliferative Disorders Leukemia, B-Cell Lymphoma |
Anti-Infective Agents Neoplasms by Histologic Type Anti-HIV Agents Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Antiviral Agents Pharmacologic Actions Neoplasms Anti-Retroviral Agents Therapeutic Uses Antirheumatic Agents |