Status:
COMPLETED
OPTIM DASATINIB (Optimized Tyrosine Kinase Inhibitors Monotherapy)
Lead Sponsor:
Versailles Hospital
Collaborating Sponsors:
Maisonneuve-Rosemont Hospital
University Hospital, Bordeaux
Conditions:
Chronic Myelogenous Leukemia, BCR/ABL Positive
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This protocol is a multicentric interventional phase II study from the French CML Intergroup (FILMC). The core of the protocol is to explore the efficacy and safety of an optimization strategy consis...
Eligibility Criteria
Inclusion
- Male or female patient ≥ 18 years
- ECOG Performance Status score 0-2
- Philadelphia chromosome positive newly diagnosed (≤ 3 months) CP-CML
- patients not previously treated except with hydroxyurea or imatinib (less than 4 weeks for imatinib)
- Signed written inform consent
- 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).
- Adequate renal function defined as serum creatinine ≤ 3 times the institutional ULN.
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception.
Exclusion
- Patients with BCR-ABL positive, Philadelphia negative CML
- Patient previously treated with a tyrosine kinase inhibitor (TKI) except with imatinib during less than 4 weeks.
- Pregnancy
- Active malignancy
- Uncontrolled or significant cardiovascular disease
- Patients with QTc \> 450 ms
- Significant bleeding disorder unrelated to CML
- Concurrent severe diseases which exclude the administration of therapy
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
289 Patients enrolled
Trial Details
Trial ID
NCT01916785
Start Date
May 1 2009
End Date
December 1 2013
Last Update
August 22 2016
Active Locations (34)
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1
Southern Alberta Cancer Research Institute
Calgary, Canada
2
Hôpital Charles LeMoyne
Greenfield Park, Canada
3
Queen elisabeth II Health Sciences Center
Halifax, Canada
4
CH Pierre LeGardeur
Lachenaie, Canada