Observational study on the use of Ivosidenib for patients with Acute Myeloid Leukemia in France
OBServatory of Compassionate Use of IVOsidenib in France for Patients With Acute Myeloid Leukemia
This study looks at how well a drug called Ivosidenib works for people in France with acute myeloid leukemia who have a specific gene mutation, to see if it helps them feel better or respond to treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | French Innovative Leukemia Organisation Academic / other |
| Locations | 21 sites (Amiens and 20 other locations) |
| Trial ID | NCT06377579 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with IDH1 R132 mutated acute myeloid leukemia who have been treated with Ivosidenib under the compassionate access program.
Not a fit: Patients who have received Ivosidenib through a clinical trial or who oppose participation in the study may not benefit.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Ivosidenib for treating AML patients with IDH1 mutations.
How similar studies have performed: Other studies have shown promising results with similar approaches targeting IDH mutations in AML, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Amiens and 20 other locations
- Amiens CHU — Amiens, France (Not_yet_recruiting)
- Angers CHU — Angers, France (Not_yet_recruiting)
- Bayonne CH — Bayonne, France (Not_yet_recruiting)
- Besançon CHU — Besançon, France (Not_yet_recruiting)
- CHU Estaing — Clermont-Ferrand, France (Recruiting)
- Créteil CHU HENRI MONDOR — Créteil, France (Recruiting)
- DUNKERQUE-Hôpital Alexandra Lepève — Dunkirk, France (Recruiting)
- Grenoble CHU — Grenoble, France (Not_yet_recruiting)
- Le Mans CH — Le Mans, France (Not_yet_recruiting)
- Lyon sud CHU — Lyon, France (Not_yet_recruiting)
- Marseille IPC — Marseille, France (Not_yet_recruiting)
- Meaux CH de l'Est francilien — Meaux, France (Recruiting)
- Montpellier - Chu Saint Eloi — Montpellier, France (Not_yet_recruiting)
- Mulhouse Chu — Mulhouse, France (Recruiting)
- Nantes CHU — Nantes, France (Recruiting)
- Nice CHU — Nice, France (Not_yet_recruiting)
- Orléans CHU — Orléans, France (Not_yet_recruiting)
- Paris Saint Louis — Paris, France (Not_yet_recruiting)
- Bordeaux CHU — Pessac, France (Not_yet_recruiting)
- ICANS - Institut de cancérologie de strasbourg europe — Strasbourg, France (Not_yet_recruiting)
- Toulouse - IUCT Oncopole - Service d'Hématologie — Toulouse, France (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.