A Prospective Randomized Phase II Study Evaluating the Monitoring of Imatinib Mesylate Plasmatic Through Level in Patients Newly Diagnosed With CP-CML
NCT ID: NCT02896842
Last Updated: 2017-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
139 participants
INTERVENTIONAL
2010-09-30
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Results from the study of Larson et al. indicate that around 40% of the patients had a trough plasmatic level below 1000 ng/ml after day 28 of imatinib 400 mg/d. The major molecular response rate at 12 months for the patients with the lower plasmatic through level is 25.4% compared to 40.1% for the patients with a plasmatic dosage over 800 to 1000 ng/ml.
Investigators propose to adapt the imatinib daily dose in case of imatinib through plasmatic level at day 28 below 1000 ng/ml. Patients with a trough plasmatic dosage ≤ 1000 ng/ml will be randomized between a prospective adaptation strategy of the imatinib daily dose (cohort 1) versus observation only (cohort 2). The patients with adequate imatinib dosage (\> 1000 ng/ml) will be followed up according the ELN recommendation (cohort 3). Imatinib trough plasmatic level will then be rechecked every month thereafter for patients in cohort 1 and cohort 2 and every three months in cohort 3. The first endpoint of the study will be the rate of major molecular response at 12 months in cohort 1. Our hypothesis is to improve the 12 months MMR rate with the optimized strategy (cohort 1) from 25% of MMR at 12 months to 40% of MMR at 12 months.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control Arm
cohort 3: Imatinib through dosage ≥ 1000 ng/ml
No interventions assigned to this group
Active comparator
Cohort 2 : Imatinib standard dose Imatinib through dosage \< 1000 ng/ml
active comparator
Experimental arm
Cohort 1 : dose adjustment based on trough plasmatic level value Imatinib through dosage \< 1000 ng/ml
Posology dose modification
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Posology dose modification
active comparator
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Philadelphia chromosome positive newly diagnosed chronic myelogenous leukaemia (≤ 4 months) in first chronic phase.
3. Not previously treated with tyrosine kinase inhibitors other than imatinib
4. Prior treatment with imatinib during less than 13 weeks
5. Signed written inform consent
6. Women of childbearing potential (WOCBP) must be using an adequate method of contraception
Exclusion Criteria
2. Patient previously treated with TKI other than imatinib
3. Pregnancy
4. Active malignancy
5. Concurrent severe diseases which exclude the administration of therapy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Versailles Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Philippe ROUSSELOT
Study coordonator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU angers
Angers, , France
CH d'Annecy
Annecy, , France
CH argenteuil
Argenteuil, , France
CHU Bordeaux
Bordeaux, , France
Institut Bergonié
Bordeaux, , France
CH Boulogne
Boulogne, , France
CHU CAEN
Caen, , France
CH de Dieppe
Dieppe, , France
CH Dunkerque
Dunkirk, , France
CH Versailles
Le Chesnay, , France
CHU Lille
Lille, , France
CHU Lyon
Lyon, , France
CH Meaux
Meaux, , France
Hopital Bon secours
Metz, , France
CHU Nice
Nice, , France
Hopital La Source
Orléans La Source, , France
Hopital Necker
Paris, , France
CHU Rennes
Rennes, , France
Hopital Purpan
Toulouse, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
09/38_ Optim Imatinib
Identifier Type: -
Identifier Source: org_study_id