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The Effect of Interleukin 11 on Thrombocytopenia Associated With Imatinib or Other Tyrosine Kinase Inhibitor Therapy in Patients With Chronic Myelogenous Leukemia
The goal of this clinical research study is to find out if IL-11 (NeumegaTM) may increase the platelet count in patients with Chronic myeloid leukemia (CML) who develop low platelet counts while receiving therapy with imatinib mesylate (Gleevec, STI571), or other tyrosine kinase inhibitors such as AMN107, dasatinib, or SK1606. Primary Objective: 1\. To determine efficacy of low-dose interleukin-11, (IL-11, oprelvekin, NeumegaTM) in improving the thrombocytopenia associate with imatinib or other tyrosine kinase inhibitor therapy in patients with CML. Secondary Objective: 1\. To determine the safety of low-dose IL-11 in patients with CML and thrombocytopenia associated with imatinib or other tyrosine kinase inhibitors
IL-11 is a hormone normally produced in your body that plays a role in stimulating the production of platelets. Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a blood sample (1 teaspoon) collected to check your platelet count. Women who are able to have children must have a negative blood pregnancy test. If you are found to be eligible to take part in this study, you will receive one injection of IL-11 under the skin (usually of the arms, legs or abdomen) 3 times a week. If your platelet count increases, treatment will continue on this schedule as long as a platelet increase is observed. If the treatment is well tolerated but there is not enough of a platelet improvement, the dose and frequency of IL-11 injections may be increased. If the platelet count becomes high enough, treatment may be stopped but may also be restarted if necessary. During therapy with IL-11, additional blood samples (1 teaspoon each) will be collected to measure the platelet count every week until the platelets are stable and then every 2 to 6 weeks while you are receiving treatment on study. No other tests are required for this study. While you are on this study, you will continue your treatment with imatinib mesylate or other tyrosine kinase inhibitor as decided by your doctor for standard care.You will be taken off if there is no response to treatment or if there are unacceptable side effects. There will be no follow-up after you go off study. This is an investigational study. The Food and Drug Administration (FDA) has approved IL-11 for use in chemotherapy-caused low platelet counts. A maximum of 30 patients will take part in this study. All will be enrolled at M. D. Anderson.
Age
All ages
Sex
ALL
Healthy Volunteers
No
UT MD Anderson Cancer Center
Houston, Texas, United States
Start Date
October 1, 2005
Primary Completion Date
January 1, 2011
Completion Date
January 1, 2011
Last Updated
February 20, 2012
8
ACTUAL participants
Interleukin-11 (IL-11 or Neumega)
DRUG
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT07388563
NCT00106925
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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