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Observational study of adults with Acute Myeloid Leukemia

A Prospective Non-interventional Study Documenting the Management and Outcomes of Adult Patients With Acute Myeloid Leukemia (AML)

Observational Acute Leukemia French Association · NCT04777916

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
Enrollment5000 (estimated)
Ages18 Years and up
SexAll
SponsorAcute Leukemia French Association Academic / other
Drugs / interventionsgemtuzumab, quizartinib, gilteritinib, chemotherapy
Locations30 sites (Amiens and 29 other locations)
Trial IDNCT04777916 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed or relapsed/refractory Acute Myeloid Leukemia.

Not a fit: Patients with acute promyelocytic leukemia or those whose AML is not morphologically proven may not benefit from this study.

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 performed: Other observational studies in AML have shown success in understanding treatment patterns and patient outcomes, indicating that this approach is supported by prior research.

Eligibility criteria

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 this trial is running

Amiens and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Myeloid Leukemia
Last reviewed 2026-06-13 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.