coiaward2010

TOPASE - Therapeutic Observatory of Ponatinib About Safety and Efficacy [France]

Study title

TOPASE - Therapeutic Observatory of Ponatinib About Safety and Efficacy

Scientific title

Observational study on CML patients in any phase of the disease, treated with ponatinib (Iclusig®)

Indication and most important inclusion criteria

This study includes patients who:
- are aged ≥18 years and agree to participate in the study
- are presenting CML in any phase
- have been receiving treatment with ponatinib for less than six months
- have the ability to understand the requirements of the study and to comply with the study data collection procedures

Short description of intervention

This is a non-interventional study. Ponatinib will be prescribed in the usual manner in accordance with the terms of the marketing authorization. All treatment decisions are made at the discretion of the patient’s healthcare provider (HCP) as per indication and are not mandated by the study design or protocol.

The study aims at better qualifying the benefit-risk balance of ponatinib in real life and in relation with the treatment history of CML patients therapeutic history.

The patient's health status will be evaluated during a 24-month follow-up. Time points for patient evaluation will be at the discretion of the investigator. It is anticipated that these will occur approximately every 3 months the first year, and then every 6 months.

• Effectiveness will be assessed on the basis of hematologic, cytogenetic and molecular response rates and survival duration (overall and progression-free) according to the center practices.
• Tolerance will be assessed by the collection of adverse events.

Type of study

Other trial

Current status

recruiting

Study sponsor

INCYTE BioSciences France

Scientific lead / contact

Prof. Ali Turhan

Principal investigator

Prof. Ali Turhan
Paris Sud University Hospitals-Bicetre & Paul Brousse
Research Director, Inserm U935 & INGESTEM Pluripotent Stem Cell Infrastructure
78 Rue du Général Leclerc, 94275 Le Kremlin Bicêtre, France 

Additional information

 

Study centers / principal investigators

France

Paris Sud University Hospitals
Prof. Ali Turhan

 

 


 
   
 

EU e-Privacy Directive