Observational study on the use of Ivosidenib for patients with Acute Myeloid Leukemia in France

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients with acute myeloid leukemia (AML) who have mutations in the IDH1 gene. It examines the effects of Ivosidenib, an oral inhibitor of mutant IDH1, in patients treated under a compassionate access program in France from January 2017 to August 2023. The study aims to gather data on the clinical activity of Ivosidenib, whether used alone or in combination with other therapies, in newly diagnosed or relapsed/refractory AML patients. By analyzing these cases, the study seeks to better understand the treatment outcomes associated with this specific mutation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient with IDH1 R132 mutated with newly diagnosed or Relapsed or Refractory (R/R) acute myeloid leukemia
* Patient treated within French compassionate access program that have started the treatment between 01/01/2017 to 01/08/2023
* patient treated by Ivosidenib received either as a monotherapy or in combination with other AML therapy (i.e. azacytidine, venetoclax)
* Patient not included within IDH inhibitor clinical trial.

Exclusion Criteria:

* Patients who expressed their opposition to entered in the study
* Patients who received IVO through a trial

Where it's running

• CHU Estaing
  Clermont-Ferrand, France Recruiting
• Créteil CHU HENRI MONDOR
  Créteil, France Recruiting
• DUNKERQUE-Hôpital Alexandra Lepève
  Dunkirk, France Recruiting
• Meaux CH de l'Est francilien
  Meaux, France Recruiting
• Mulhouse Chu
  Mulhouse, France Recruiting
• Nantes CHU
  Nantes, France Recruiting

Study contacts

• Principal investigator: Pierre PETERLIN, Dr — French Innovative Leukemia Organisation
• Study coordinator: Ariane MINEUR
• Email: ariane.mineur@chu-bordeaux.fr
• Phone: +33 (0)5 57 62 31 08

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.