Observational study of adults with Acute Myeloid Leukemia
Official title: A Prospective Non-interventional Study Documenting the Management and Outcomes of Adult Patients With Acute Myeloid Leukemia (AML)
Run by Acute Leukemia French Association · NCT04777916 · Data updated 2026-11-12
This study looks at adults with Acute Myeloid Leukemia to see how their diagnosis and treatment have changed over the last fifteen years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | Acute Leukemia French Association Academic / other |
| Drugs / interventions | gemtuzumab, quizartinib, gilteritinib, chemotherapy |
| Locations | 30 sites (Amiens and 29 other locations) |
| Status | Recruiting |
| Started | April 14, 2022 |
| Main results expected | April 1, 2032 |
| Study ends | April 1, 2046 |
| Registry record updated | October 3, 2025 |
| Trial ID | NCT04777916 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with newly diagnosed or relapsed/refractory Acute Myeloid Leukemia.
✕Probably not a fit
Patients with acute promyelocytic leukemia or those whose AML is not morphologically proven may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to observe adult patients diagnosed with Acute Myeloid Leukemia (AML) to understand the evolving landscape of diagnosis and treatment options over the past fifteen years. It will include patients who are newly diagnosed, untreated, or those with relapsed/refractory AML, focusing on the diversity of patient journeys influenced by genetic and prognostic factors. The study will document the standard treatment options available, including various chemotherapy regimens and the use of new drugs, while also considering the characteristics of each patient. Amendments may be made to the study as new treatment standards emerge.
Why it matters
Potential benefit: If successful, this study could enhance understanding of AML treatment pathways and improve patient outcomes through better-tailored therapies.
How similar studies have gone: Other observational studies in AML have shown success in understanding treatment patterns and patient outcomes, indicating that this approach is supported by prior research.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged 18 years old or more * Patient with newly diagnosed previously untreated de novo, secondary or therapy-related AML * Patients with R/R de novo, secondary or therapy-related AML * Patient with Health insurance Exclusion Criteria: * Acute promyelocytic leukemia * AML which is not morphologically proven (patients with granulocytic sarcoma may be included) * For newly diagnosed AML: previous treatment of leukemia apart from hydroxyurea. Previous anti leukemia treatments are allowed if they were administered before the diagnosis of AML to treat a MDS, MPN, MPN/MDS or CML * Patient weighting less than 50 kgs * Opposition of the patient to participate to this non-interventional study More specific eligibility criteria might be requested to enter some study modules
Where it's running
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Chu Amiens
Amiens, France Recruiting -
Centre Hospitalier Victor Dupouy
Argenteuil, France Recruiting -
AP-HP-GHU - Hôpital AVICENNE
Bobigny, France Recruiting -
CHU de la cote de Nacre
Caen, France Recruiting -
Hôpital MILITAIRE PERCY
Clamart, France Recruiting -
Centre hospitalier Sud Francilien
Corbeil-Essonnes, France Recruiting
Show 24 more locations
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Hôpital Henri Mondor AP-HP
Créteil, France Recruiting -
Centre Hospitalier de Dunkerque
Dunkirk, France Recruiting -
Centre Hospitalier de Versailles André Mignot
Le Chesnay, France Recruiting -
Centre Hospitalier Dr Schaffner
Lens, France Recruiting -
CHRU de Lille- Hopital C. HURIEZ
Lille, France Recruiting -
GHICL-Hopital St Vincent de Paul
Lille, France Recruiting -
C H U DE LIMOGES- Hopital Dupuytren
Limoges, France Recruiting -
CHU La Conception
Marseille, France Recruiting -
Centre Hopsitalier de l'Est Francilien - Site de Meaux
Meaux, France Recruiting -
Centre Antoine Lacassagne
Nice, France Recruiting -
CHU Nice,Hopital Archet 1
Nice, France Recruiting -
Hopital Pitié-Salpétrière APHP
Paris, France Recruiting -
Hôpital Necker - APHP
Paris, France Recruiting -
Hôpital SAINT ANTOINE-APHP
Paris, France Recruiting -
Hôpital Saint Louis- APHP
Paris, France Recruiting -
Centre Hospitalier Lyon Sud
Pierre-Bénite, France Recruiting -
Centre Hospitalier René Dubos
Pontoise, France Recruiting -
Centre Hospitalier de Roubaix
Roubaix, France Recruiting -
Centre Henri Becquerel
Rouen, France Recruiting -
Centre Hospitalier de St Quentin
Saint-Quentin, France Recruiting -
Institut Gustave Roussy
Villejuif, France Recruiting -
CHU Dijon- François Mitterrand
Dijon, France Active not recruiting -
Institut Curie - Hôpital René HUGUENIN
Saint-Cloud, France Not yet recruiting -
Centre Hospitalier Valenciennes
Valenciennes, France Not yet recruiting
Study contacts
- Study coordinator: Karine CELLI LEBRAS, Mrs
- Email: karine.cellilebras@alfa-leukemia.org
- Phone: 33 1 57 27 67 17
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PBSS1113 with azacitidine for AML and higher-risk MDS
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-
CAR-T cells targeting CD33 and CLL1 for relapsed or refractory AML
A one-arm early-stage trial tests whether a patient’s own engineered CAR-T cells (ICG415) can be safely given after conditioning chemotherapy to see if they can help adults with relapsed or refractory AML.
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Ziftomenib for relapsed/refractory NPM1-mutated AML in Japanese adults
This study will test whether ziftomenib can help adults with relapsed or refractory NPM1-mutated AML who have few other options.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.