Trial Information

Summary: Adults with Chronic Myelogenous Leukemia Sought for Research Study.

UVA Health System, Cancer Center, seeks adults over the age of 18, with chronic myelogenous leukemia in chronic phase (CML-CP) for a research study.

The purpose of this research study is to find the best treatment for CML-CP patients who have been recently diagnosed with CML in chronic phase by comparing the benefits and side effects of two medications. The medications are called Gleevec (imatinib) and nilotinib. Participants who qualify, will be randomly assigned to receive tablet form medications of either 600 mg. of nilotinib, 800 mg. of nilotinib, or 400 mg. of imatinib. Participants will be seen by the study team at the UVA Cancer Center once a week during the first cycle of treatment (4 visits in first month) once every 28 days for the next 5 months, and then study visits will occur every 3 months up to 4 ½ years or as long as the drug is effective. Participants will undergo the following tests before and during the study: physical exams, blood tests, pregnancy test (if applicable), echocardiograms, ECGs, bone marrow biopsies and health surveys. The study medications, Gleevec and Nilotinib, will be provided by the sponsor. The sponsor will also pay for treatments and procedures directly related to the study. The participants insurance company will be billed for the costs of standard of care treatments and procedures. There will be no financial compensation for participating in this study.

Contact Information:
For more information please contact:
Maryann Lincoln RN BSN CCRP
Phone: 434-982-0722
Email: ML6S@virginia.edu
IRB-HSR #13247
Principal Investigator: Michael Douvas, MD



www.healthsystem.virginia.edu/clinical_trials

If you would like to learn more about participating in this study, please send an e-mail message using the form below.