NCT01827930

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

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 Cytogenetic Response for at Least One Year

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Leukemia, Myeloid, Chronic-Phase

Interventions

Type	Name	Description
DRUG	Imatinib Mesylate 600 MG Oral Tablet	Imatinib Mesylate for CP CML
DRUG	Imatinib Mesylate 400 MG Oral Tablet	Imatinib Mesylate for CP CML
DRUG	Imatinib Mesylate	Imatinib Mesylate for CP CML

Timeline

• Start date: 2009-07-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2013-04-10
• Last updated: 2020-12-31
• Results posted: 2020-12-31

Locations

1 site across 1 country: France