Chronic Myelogenous Leukemia, BCR/ABL Positive Clinical Trial
Official title:
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).
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment