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Evaluating cytokine levels in patients with acute myeloid leukemia

Validation Study of a New Cytokine-based Dynamic Stratification Based on FLt3 Ligand Plasma Concentration Kinetic Profile and IL-6 Concentration During Induction of Acute Myeloid Leukemia

Observational Nantes University Hospital · NCT04641910

This study is trying to see if measuring certain proteins in the blood can help doctors better understand and treat patients with acute myeloid leukemia.

Quick facts

Study typeObservational
Enrollment201 (estimated)
Ages18 Years and up
SexAll
SponsorNantes University Hospital Academic / other
Drugs / interventionsgemtuzumab, chemotherapy
Locations25 sites (Strasbourg, Bas-Rhin and 24 other locations)
Trial IDNCT04641910 on ClinicalTrials.gov

What this trial studies

This observational study aims to validate a new method of dynamic stratification for patients with acute myeloid leukemia (AML) based on the kinetic profiles of Fms-like tyrosine kinase 3 ligand (FL) and interleukin-6 (IL-6) concentrations during induction therapy. The study will analyze previously collected serum samples to assess the impact of various cytokines on patient outcomes. By categorizing patients into risk groups based on their FL levels, the researchers hope to improve prognostic accuracy and treatment strategies for AML. No new interventions will be administered as part of this study.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of non-treated acute myeloid leukemia eligible for standard induction chemotherapy.

Not a fit: Patients with acute promyelocytic leukemia or those under guardianship may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the ability to predict patient outcomes and tailor treatment approaches for those with acute myeloid leukemia.

How similar studies have performed: Previous studies have shown promising results in using cytokine levels for prognostic stratification in acute myeloid leukemia, suggesting this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age \>= 18 years old
* Confirmed diagnosis of AML according to World Health Organization (WHO) 2016 classification (Arber et al., 2016)
* Non previously treated AML (first-line therapy)
* Patients eligible to standard 3+7 induction chemotherapy with a minimum of 3 days of daunorubicin at 45mg/m2/day or a minimum of 5 days of idarubicin at 8mg/m2/day and a minimum of 7 days of cytarabin at 100mg/m2/day
* Patients receiving any "third drug" combined to the "3+7" scheme, i.e. lomustine, corticotherapy, elthrombopag, gemtuzumab-ozogamycin, any FLT3 inhibitors... are eligible
* Patients receiving CPX-351 (Vyxeos ®) are eligible
* Patients requiring leukapheresis are eligible
* Signed informed consent

Exclusion Criteria:

* Patients diagnosed with Acute Promyelocytic Leukemia (AML-3)
* Adults under guardianship, subjects under protection.

Where this trial is running

Strasbourg, Bas-Rhin and 24 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.