Phase II Study of 5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia
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anesthetic, and a small amount of bone marrow is withdrawn through a large needle.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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor Response Rate (Complete, Partial)
Approximately every 3-8 weeks.
Zeev Estrov, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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