Clinical trial Recruiting at 27 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment5000 (estimated)
SponsorAcute Leukemia French Association
Academic / other
Drugs / interventionsgemtuzumab, quizartinib, gilteritinib, chemotherapy
Locations30 sites (Amiens and 29 other locations)
StatusRecruiting
StartedApril 14, 2022
Main results expectedApril 1, 2032
Study endsApril 1, 2046
Registry record updatedOctober 3, 2025
Trial IDNCT04777916 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • PBSS1113 with azacitidine for AML and higher-risk MDS

    This study tests PBSS1113 together with azacitidine to see if it is safe and may help people with AML or higher-risk MDS who are newly diagnosed and not fit for intense chemotherapy or who have relapsed/refractory disease.

    Recruiting Phase 1/2 Chaser Therapeutics, Inc. · Hangzhou, Zhejiang · NCT07761533

  • Caris Chromoseq data collection for AML, MDS, and MPN

    This study tests how well the Caris Chromoseq assay helps categorize risk in patients with AML, MDS, or MPN compared with standard tests.

    Recruiting Caris Science, Inc. · Phoenix, Arizona · NCT07680868

  • Venetoclax TDM in newly diagnosed AML: exposure and prognosis

    This study checks if measuring venetoclax levels and adjusting treatment helps people with newly diagnosed AML who are getting VEN-AZA.

    Recruiting The First Affiliated Hospital of Soochow University · Suzhou · NCT07670130

  • 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.

    Recruiting at 2 sites Phase 1 iCell Gene Therapeutics · Nanchang, Jiangxi and 1 other locations · NCT07668557

  • 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.

    Recruiting at 15 sites Phase 2 Kyowa Kirin Co., Ltd. · Chiba and 19 other locations · NCT07623616

  • VABu Conditioning for elderly AML patients undergoing stem cell transplant

    This trial tests a VABu conditioning regimen to see if it helps older AML patients before allogeneic stem cell transplantation.

    Recruiting Phase 2/3 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07583888

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.