NCT01916785

OPTIM DASATINIB (Optimized Tyrosine Kinase Inhibitors Monotherapy)

A PROSPECTIVE RANDOMIZED PHASE II STUDY EVALUATING THE OPTIMIZATION OF THE RESIDUAL PLASMATIC LEVEL OF DASATINIB (SPRYCEL®) IN PATIENTS NEWLY DIAGNOSED WITH CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 289 (actual)
• Sponsor: Versailles Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Chronic Myelogenous Leukemia, BCR/ABL Positive

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2009-05-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-08-06
• Last updated: 2016-08-22

Locations

34 sites across 2 countries: Canada, France