Status:
TERMINATED
Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of Imatinib Mesylate on the Molecular Response
Lead Sponsor:
Institut Bergonié
Collaborating Sponsors:
Novartis
Conditions:
Leukemia, Myeloid, Chronic-Phase
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 molec...
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 molec...
Eligibility Criteria
Inclusion
- Patients with CML-CP treated for at least two years by Imatinib Mesylate 400 mg / d,
- Patients in complete cytogenetic response for at least 1 year
- Patients with residual disease detectable by quantitative RT-PCR (RQ-PCR)
- ECOG ≤ 2,
- Age ≥ 18 years
- Signed informed consent,
- Membership of a social security system
Exclusion
- Patients with CML-CP Philadelphia chromosome negative diagnosis.
- Patients previously treated with Imatinib Mesylate at doses above 400 mg / day
- Patient with non-hematologic toxicity of grade III or IV in Imatinib Mesylate 400mg / d
- Patient with a medical condition endocrine, psychiatric, neurological, renal, hepatic or cardiac progressive uncontrolled by medical treatment
- Pregnant or breastfeeding women, women of childbearing potential not using a contraceptive method effective
- Known HIV positive
- Patients previously treated with another tyrosine kinase inhibitor
- Patient participating in another interventional clinical trial
- History of non-compliance to Imatinib Mesylate
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01827930
Start Date
July 1 2009
End Date
January 1 2017
Last Update
December 31 2020
Active Locations (1)
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1
Institut Bergonié
Bordeaux, Aquitaine, France, 33000