OPTIM DASATINIB (Optimized Tyrosine Kinase Inhibitors Monotherapy)
NCT ID: NCT01916785
Last Updated: 2016-08-22
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
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COMPLETED
PHASE2
289 participants
INTERVENTIONAL
2009-05-31
2013-12-31
Brief Summary
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The core of the protocol is to explore the efficacy and safety of an optimization strategy consisting in the modulation of the dasatinib daily dose according to the results of repeated plasmatic levels of dasatinib.
The objective of this strategy is to improve the overall results of the treatment of early CP-CML in order to avoid the development of resistance and BCR-ABL tyrosine kinase mutations.
The study will be conducted in selected FILMC and Canadian centers.
The study is sponsored by the Hôpitaux de Versailles and supported by Bristol-Myers Squibb. The dasatinib treatment will be provided by Bristol-Myers Squibb until marketing authorization is granted in that indication.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A1
Arm A1: Dasatinib dose adjustment based on Cmin ≥3nM value analysed on blood after 7-10 days dasatinib 100mg intake
Dasatinib
Dasatinib is a multitargeted tyrosine kinase inhibitor with a 300-fold more potent activity on the BCR-ABL tyrosine kinase in vitro compared to imatinib mesylate
A2
Arm A2: Dasatinib standard dose (100mg/d) with Cmin ≥ 3nM analysed on blood after 7-10 days dasatinib 100mg intake
Dasatinib
Dasatinib is a multitargeted tyrosine kinase inhibitor with a 300-fold more potent activity on the BCR-ABL tyrosine kinase in vitro compared to imatinib mesylate
B
Arm B : Dasatinib standard dose with Cmin \< 3nM analysed on blood after 7-10 days dasatinib 100mg intake
Dasatinib
Dasatinib is a multitargeted tyrosine kinase inhibitor with a 300-fold more potent activity on the BCR-ABL tyrosine kinase in vitro compared to imatinib mesylate
Interventions
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Dasatinib
Dasatinib is a multitargeted tyrosine kinase inhibitor with a 300-fold more potent activity on the BCR-ABL tyrosine kinase in vitro compared to imatinib mesylate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. ECOG Performance Status score 0-2
3. Philadelphia chromosome positive newly diagnosed (≤ 3 months) CP-CML
4. patients not previously treated except with hydroxyurea or imatinib (less than 4 weeks for imatinib)
5. Signed written inform consent
6. Adequate hepatic function defined as: total bilirubin ≤ 2.0 times the institutional ULN; ALT and AST ≤ 2.5 times the institutional upper limit of normal (ULN).
7. Adequate renal function defined as serum creatinine ≤ 3 times the institutional ULN.
8. Women of childbearing potential (WOCBP) must be using an adequate method of contraception.
Exclusion Criteria
2. Patient previously treated with a tyrosine kinase inhibitor (TKI) except with imatinib during less than 4 weeks.
3. Pregnancy
4. Active malignancy
5. Uncontrolled or significant cardiovascular disease
6. Patients with QTc \> 450 ms
7. Significant bleeding disorder unrelated to CML
8. Concurrent severe diseases which exclude the administration of therapy
18 Years
ALL
No
Sponsors
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Maisonneuve-Rosemont Hospital
OTHER
University Hospital, Bordeaux
OTHER
Versailles Hospital
OTHER
Responsible Party
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Philippe ROUSSELOT
Clinical Coordinator
Principal Investigators
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Philippe ROUSSELOT, Professeur hémato-oncologie
Role: PRINCIPAL_INVESTIGATOR
Versailles Hospital
Locations
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Southern Alberta Cancer Research Institute
Calgary, , Canada
Hôpital Charles LeMoyne
Greenfield Park, , Canada
Queen elisabeth II Health Sciences Center
Halifax, , Canada
CH Pierre LeGardeur
Lachenaie, , Canada
Moncton City Hospital
Moncton, , Canada
Hôpital Général Juif - Sir. Mortimer B. Davis
Montreal, , Canada
Hôpital Maisonneuve-Rosemont
Montreal, , Canada
Hôpital Royal Victoria
Montreal, , Canada
Hôpital de l'Enfant Jésus - Centre hospitalier affilié universitaire de Québec
Québec, , Canada
Pavillon Hôtel-Dieu de Québec - Centre hospitalier universitaire de Québec
Québec, , Canada
CHU Angers
Angers, , France
Hôpital Avicenne
Bobigny, , France
Institut Bergonie
Bordeaux, , France
Hopital MORVAN
Brest, , France
CH René Dubos
Cergy-Pontoise, , France
Hôpital d'Instruction de Armées Percy
Clamart, , France
Hopital Henri MONDOR
Créteil, , France
Hôpital Claude Huriez
Lille, , France
CH Lyon Sud
Lyon, , France
Institut Paoli-Calmettes
Marseille, , France
Hôpital d'Annecy
Metz-Tessy, , France
C.H.U. Brabois
Nancy, , France
CHU Hoptel dieu
Nantes, , France
Hôpital l'Archet 1
Nice, , France
CHU Caremeau
Nîmes, , France
Hopital Saint Louis
Paris, , France
Hôpital Necker-Enfants Malades
Paris, , France
Hôpital St Antoine
Paris, , France
CHU Poitiers
Poitiers, , France
CHU Rennes - Pontchaillou
Rennes, , France
Centre René Huguenin
Saint-Cloud, , France
Hôpital Purpan
Toulouse, , France
CHRU Bretonneau
Tours, , France
Central Hospital
Versailles, , France
Countries
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References
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Rousselot P, Mollica L, Guilhot J, Guerci A, Nicolini FE, Etienne G, Legros L, Charbonnier A, Coiteux V, Dartigeas C, Escoffre-Barbe M, Roy L, Cony-Makhoul P, Dubruille V, Gardembas M, Huguet F, Rea D, Cayssials E, Guilhot F, Bergeron A, Molimard M, Mahon FX, Cayuela JM, Busque L, Bouchet S. Dasatinib dose optimisation based on therapeutic drug monitoring reduces pleural effusion rates in chronic myeloid leukaemia patients. Br J Haematol. 2021 Jul;194(2):393-402. doi: 10.1111/bjh.17654. Epub 2021 Jun 30.
Other Identifiers
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EudraCT 2008-006854-17
Identifier Type: -
Identifier Source: org_study_id
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