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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Celgene Corporation |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00413478 |
The objective of this study is to determine the safety and efficacy of Azacytidine in fludarabine-resistant chronic lymphocytic leukemia (CLL), Richter's transformation, and T-cell prolymphocytic leukemia (T-PLL).
Condition | Intervention | Phase |
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Chronic Lymphocytic Leukemia Leukemia |
Drug: 5-Azacytidine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of 5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 37 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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5-Azacytidine: Experimental |
Drug: 5-Azacytidine
75mg/m^2 subcutaneously daily for seven days. Treatment cycles will be repeated every 3-8 weeks.
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Azacytidine is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes may be able to work better.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have blood drawn (about 3 teaspoons) to check your kidney and liver function (routine blood tests). You may have a bone marrow aspiration performed (if you have not had one in recent weeks). To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. Women who are able to have children must have a negative urine pregnancy test.
If you agree to take part in this study, you will receive azacytidine by subcutaneous (just under the skin) injection every day for 7 days. This course of treatment will be repeated every 3-8 weeks, depending on the results of your routine blood tests.
Your doctor may increase or decrease your dose of azacytidine, depending on if you experience any side effects.
You will continue to receive treatment on this study unless the disease gets worse or you experience any intolerable side effects. If the disease gets worse or you experience any intolerable side effects, you will be taken off this study.
This is an investigational study. This is an investigational study. Azacytidine has been approved by the FDA for the treatment of myelodysplastic syndrome. Up to 37 patients will take part in this study. All will be enrolled at M. D. Anderson.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Zeev Estrov, MD | 713-794-1675 | zestrov@mdanderson.org |
United States, Texas | |
The University of Texas M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Zeev Estrov, MD 713-794-1675 | |
Principal Investigator: Zeev Estrov, MD |
Principal Investigator: | Zeev Estrov, MD | M.D. Anderson Cancer Center |
Responsible Party: | The University of Texas M.D. Anderson Cancer Center ( Zeev Estrov, M.D., Professor ) |
Study ID Numbers: | 2006-0428 |
Study First Received: | December 15, 2006 |
Last Updated: | August 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00413478 History of Changes |
Health Authority: | United States: Institutional Review Board |
5-Aza Azacytidine Vidaza CLL |
Chronic Lymphocytic Leukemia Richter's transformation Leukemia |
Antimetabolites Richter Syndrome Lymphatic Diseases Leukemia Chronic Lymphocytic Leukemia Leukemia, Lymphoid |
Immunoproliferative Disorders Leukemia, Lymphocytic, Chronic, B-Cell Azacitidine Leukemia, B-cell, Chronic Lymphoproliferative Disorders Leukemia, B-Cell |
Antimetabolites Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Enzyme Inhibitors |
Pharmacologic Actions Leukemia Lymphatic Diseases Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Azacitidine Leukemia, B-Cell Lymphoproliferative Disorders |