CML1113 (GIMEMA)

The GIMEMA CML Working Party promotes a multicentric, observational, non company sponsored, prospective study of Chronic Myeloid Leukemia (CML) patients treated frontline with dasatinib. Patients will be followed for 5 years. This study will help the definition of guidelines for the treatment of CML patients in early phases.

This study is currently recruiting participants. (see Contacts and Locations)

Verified January 2014 by Gruppo Italiano Malattie EMatologiche dell'Adulto

Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Information provided by (Responsible Party): Gruppo Italiano Malattie EMatologiche dell'Adulto

First received: January 30, 2013

The primary objective of the study is to describe, in the clinical practice, the rate of events leading to permanent discontinuation after 2 years of treatment with dasatinib as frontline therapy in newly diagnosed CML patients.

In summary

1. Most data on second generation TKIs are from company-sponsored studies
2. The high rate of study discontinuation observed within the phase III study may influence the data interpretation
3. A long-term post-marketing surveillance in large independent trial is extremely important to confirm the efficacy in a nationwide experience
4. The persistence of CMR after TKI discontinuation have been described in selected patients with "deep" molecular response
5. A stable CMR is a pre-requisite for treatment discontinuation
6. A detailed description of the kinetic of the molecular response, potentially related to a subsequent treatment discontinuation, will be done.