OBServatory of Compassionate Use of IVOsidenib in France for Patients With Acute Myeloid Leukemia

Plain-language summary

This observational study looks at data from patients with acute myeloid leukemia (AML) who used the drug Ivosidenib under a compassionate-use access program in France. It includes patients with an IDH1 R132 mutation and newly diagnosed or relapsed/refractory AML who started treatment between January 1, 2017 and August 1, 2023. It is a study with no assigned phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

French Innovative Leukemia Organisation

Start date

7/31/2024

Estimated completion

6/1/2026

Countries

France

Related genes

Locations

• Amiens, France
• Angers, France
• Bayonne, France
• Besançon, France
• Clermont-Ferrand, France
• Créteil, France
• Dunkirk, France
• Grenoble, France
• Le Mans, France
• Lyon, France
• Marseille, France
• Meaux, France
• Montpellier, France
• Mulhouse, France
• Nantes, France
• Nice, France
• Orléans, France
• Paris, France
• Pessac, France
• Strasbourg, France
• Toulouse, France

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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