Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of Imatinib Mesylate on the Molecular Response (MIM)
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
Sponsor: Institut Bergonié
Terminated
Difficulties of enrolment of Patient
This PHASE3 trial investigates Leukemia, Myeloid, Chronic-Phase and is currently terminated or withdrawn. Institut Bergonié leads this study, which shows 9 recorded versions since 2009 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)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.
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.
Status Flow
Change History
9 versions recorded-
Jan 2026 — Present [monthly]
Terminated PHASE3
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Sep 2024 — Present [monthly]
Terminated PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE3
-
Jan 2023 — Jul 2024 [monthly]
Terminated PHASE3
-
Dec 2022 — Jan 2023 [monthly]
Terminated PHASE3
▶ Show 4 earlier versions
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Jan 2021 — Dec 2022 [monthly]
Terminated PHASE3
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Jun 2018 — Jan 2021 [monthly]
Terminated PHASE3
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Dec 2017 — Jun 2018 [monthly]
Terminated PHASE3
Status: Recruiting → Terminated
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Jan 2017 — Dec 2017 [monthly]
Recruiting PHASE3
First recorded
Jul 2009
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Institut Bergonié
- Novartis
For direct contact, visit the study record on ClinicalTrials.gov .