An observational study - Evaluation of efficacy and safety of Bosulif® under real life conditions of use (BOSEVAL)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/8232
• EU PAS number:
  EUPAS8231
• Study ID:
  8232
• Official title and acronym:
  An observational study - Evaluation of efficacy and safety of Bosulif® under real life conditions of use (BOSEVAL)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  This trial is a national, observational, descriptive, prospective study conducted in France on adult patients treated for Philadelphia positive (Ph+) CML in the chronic, accelerated or blast phase, previously treated with one or more TKIs and for whom imatinib, dasatinib or nilotinib are not considered as appropriate treatments. CML is a rare disease, a minimum number of patients is not expected but a total of about one hundred (100) patients included in the study appears to be a reasonable objective. This non-interventional study is designed to evaluate the safety and efficacy, and the methods of use of Bosulif®, under real life conditions.
• Study status:
  Finalised

Research institution and networks

Institutions

Pfizer

Multiple centres: 23 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 10/02/2015

Study start date

Planned: 01/04/2015

Actual: 24/10/2015

Date of final study report

Planned: 31/01/2024

Actual: 31/05/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

B1871047_Protocole v1.1 _16032015-EN .pdf

Updated protocol

B1871047_Protocole v2 _Amendment 1_ 15022019_Clean_English.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable