Cross-sectional study to assess the effectiveness of the patients’ alert card to inform on the risk of differentiation syndrome in AML patients treated with TIBSOVO® (Ivosidenib) (IMPACTA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000190
• EU PAS number:
  EUPAS1000000190
• Study ID:
  1000000190
• Official title and acronym:
  Cross-sectional study to assess the effectiveness of the patients’ alert card to inform on the risk of differentiation syndrome in AML patients treated with TIBSOVO® (Ivosidenib) (IMPACTA)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Netherlands
• Study description:
  A Patient Alert Card (PAC) is part of an additional risk minimization measure for differentiation syndrome in acute myeloid leukemia (AML) indication, focusing on the key elements to alert patients on the symptoms of differentiation syndrome and the importance of seeking medical advice. The PAC will be distributed inside each pack of ivosidenib. ; A dedicated study for measuring effectiveness of additional risk minimisation measures on differentiation syndrome (PAC) will be conducted. This study will be classified as a Post-Authorisation Safety Study (PASS) and will follow the European (EU) Good Pharmacovigilance Practices (GVP) Module XVI and VIII guidelines.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Institut de Recherches Internationales Servier

Study timelines

Date when funding contract was signed

Planned: 18/07/2023

Actual: 18/07/2023

Study start date

Planned: 09/11/2023

Actual: 25/04/2024

Date of final study report

Planned: 30/05/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Institut de Recherches Internationales Servier

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)