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Comparing Treatments for Chronic Myelogenous Leukemia
Untitled Document
Name of the Trial
Phase II Randomized Study of Imatinib Mesylate at Standard Versus Increased
Dose or Dasatinib in Patients With Previously Untreated Chronic Phase Chronic
Myelogenous Leukemia (SWOG-S0325). See the protocol
summary.
Principal Investigators
Dr. Brian Druker and Dr. Marilyn Slovak, SWOG;
Dr. Peter Emanuel, ECOG; Dr. Martha
Wadleigh, CALGB; Dr. Jeffrey Lipton, NCIC.
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Dr. Brian Druker
Principal Investigator |
Why This Trial Is Important
Development and approval of the drug imatinib (Gleevec) revolutionized the
treatment of chronic myelogenous leukemia (CML). CML is usually characterized
by a genetic mutation, called the Philadelphia chromosome, that results in the
creation of an abnormal protein called Bcr-Abl. Imatinib inhibits the activity
of Bcr-Abl, thereby blocking the uncontrolled growth of CML cells and causing
them to die.
However, imatinib does not work for some patients, and it sometimes stops working
if CML cells develop resistance to it. Therefore, researchers are interested
in determining whether the standard dose of imatinib used as initial therapy
for CML should be changed, or if a different targeted drug might be more effective.
In this trial, doctors will compare the effectiveness of imatinib at the standard
dose versus an increased dose and against a new drug called dasatinib (Sprycel).
Dasatinib binds to the Bcr-Abl protein more readily than imatinib and has demonstrated
the ability to kill CML cells that have become resistant to imatinib.
"The current standard treatment for CML is 400 mg of imatinib a day,"
said Dr. Druker, "and that produces a response in about 90 percent of patients.
Treatment for this disease is evolving rapidly, however, and newer, more-potent
drugs are now available. With this trial, we hope to define the best treatment
options for patients newly diagnosed with CML."
Who Can Join This Trial
Researchers will enroll approximately 335 patients with previously untreated,
chronic-phase CML. See the list
of eligibility criteria.
Study Sites and Contact Information
Study sites in the United States are recruiting patients for this trial. See
the list
of study contacts or call the NCI's Cancer Information Service at 1-800-4-CANCER
(1-800-422-6237) for more information. The toll-free call is confidential.
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