Clinical Trial: Therapy of Early Chronic Phase CML With Gleevec
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Gleevec (STI571)
Brief Summary:
The goal of this clinical research study is to see if imatinib mesylate (Gleevec, STI571) can improve CML in chronic phase.
Objectives:
Primary Objective:
To increase the proportion of patients achieving a complete cytogenetic response in patients with Ph-positive early chronic phase CML using initial Gleevec therapy.
Secondary Objective:
To evaluate the duration of cytogenetic response, duration of hematologic response and survival.
Detailed Summary:
Before treatment starts, patients will have a physical exam including medical history and documentation of disease, blood tests, and a bone marrow study. The bone marrow will be removed with a large needle.
Patients on this study will take 400 mg of imatinib daily (morning or evening). If you have side effects, the dose may be lowered. If the response is not good, the dose of imatinib mesylate will be increased to 800 mg daily (400 mg in the morning and 400 mg in the evening) or may be decreased to 300 mg daily based on how the drug is tolerated. Imatinib mesylate should be taken with a large glass of water. Bottles containing the tablets will be given to the patient every 6 months. Unused supplies must be returned at the end of the study.
After completing 3 to 12 months of therapy, response to imatinib mesylate will be evaluated. If the response is good, treatment with imatinib mesylate alone will be continued. Treatment may be continued for up to 20 years, or as long as it is judged best to control the leukemia.
Update: June 2010:
Blood tests are recommended 2 times per year. Your doctor will discuss with you how often you should have blood tests. Bone marrow will be done if your doctor thinks it is necessary to check your disease. You must return to MD Anderson at least once every year. You may not need a bone marrow test every visit, but you will have blood drawn to measure the amount of disease you have. If the leukemia cannot be found for 2 years or longer on the blood test called PCR which is done to measure the amount of disease you have, your doctor may talk to you about stopping treatment with imatinib. If you and your doctor decide to stop your therapy, you will have a blood test for PCR done every 3 to 6 months.
Sponsor: M.D. Anderson Cancer Center
Current Primary Outcome: Number of patients achieving complete cytogenetic response using initial Gleevec therapy [ Time Frame: Baseline to 12 Months ]
Original Primary Outcome:
Current Secondary Outcome: Duration of cytogenic response, hematologic response and survival [ Time Frame: Baseline, 12 Months, 2 Years or until disease progression ]
Original Secondary Outcome:
Information By: M.D. Anderson Cancer Center
Dates:
Date Received: November 5, 2002
Date Started: March 2001
Date Completion:
Last Updated: January 19, 2016
Last Verified: January 2016
