Clinical Trial: Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of Imatinib Mesylate on the Molecular Response

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of IM on the Molecular Response in Patients With LMC in Chronic Phase Treated With IM 400 mg / Day for at Least Two Years, Complete Cy

Brief Summary: The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib.

Detailed Summary: The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib. This study aims to evaluate the effectiveness of a strategy for dose adjustment of Imatinib Mesylate based on the measurement of the residual plasma imatinib in patients treated for at least 2 years Imatinib 400 mg / d in complete cytogenetic response for at least 1 year.
Sponsor: Institut Bergonié

Current Primary Outcome: Compare the effectiveness of a strategy to adapt dosage of Imatinib Mesylate (based on residual plasma IM), the effectiveness of a standard (IM fixed dose of 400 mg / day ) [ Time Frame: 07/2013 (up to 12 months) ]

Compare the effectiveness of a strategy to adapt dosage of Imatinib Mesylate (based on residual plasma IM), the effectiveness of a standard (IM fixed dose of 400 mg / day )


Original Primary Outcome: Same as current

Current Secondary Outcome: Evaluate the rate and time to reach the complete molecular response at 6, 9 and 12 months [ Time Frame: 07/2013 (6, 9, and 12 months) ]

Evaluate the rate and time to reach the complete molecular response at 6, 9 and 12 months Evaluate the rate and time to reach the major molecular response at 6, 9 and 12 months Evaluate the rate and time to obtain a first rate BCR-ABL undetectable at 6, 9 and 12 months Evaluate overall survival and progression-free survival at 12 months To evaluate the safety of the IM.


Original Secondary Outcome: Same as current

Information By: Institut Bergonié

Dates:
Date Received: November 5, 2012
Date Started: July 2009
Date Completion: December 2018
Last Updated: November 8, 2016
Last Verified: November 2016