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NCT Number: NCT04641910

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

The investigators have recently demonstrated the strong impact in terms of survivals of Fms-like tyrosine kinase 3 ligand (FL) levels evaluated during intensive induction in acute myeloid leukemia (AML) patients. Indeed, three FL kinetic profiles were delineated: i) sustained increase of FL concentrations between day (D) 1 and D22 (FLI group, n=26, good-risk), ii) increase from D1 to D15, then decrease at D22 (FLD group, n=22, intermediate-risk) and iii) stagnation of low levels (<1000 pg/mL, FLL group, n=14, high-risk). However, with longer follow-up, the investigators have observed that FLI and FLD shared similar outcomes while FLL sub-group kept a very bad prognostic.

Because serum samples from this previous study (called the FLAM/FLAL study) had been frozen-stored, the investigators were able to conduct an ancillary study assessing the potential impact of the kinetics of 6 other cytokines: TNFalpha, stem-cell factor, IL-1beta, IL-6, IL-10 and granulocyte-monocyte colony-stimulating factor (GM-CSF).. Only Il-6 level at D22 (< or >15.5 pg/mL) was associated with outcome allowing to distinguish between higher and lower survivals within the combined FLI/FLD sub-group.

A new prognostic risk-stratification can thus be proposed as follows: FLI/FLD with IL-6 <15.5 pg/mL (favorable), FLI/FLD with IL-6 >15.5 pg/mL (intermediate) and FLL (high-risk).

The aim of this new FLAMVAL study is to validate prospectively in a larger and independent cohort this prognostic risk-stratification i.e. that kinetic profile of FLT3L plasma level from D1 to D22 and Il6 plasma level at day 22 during induction of AML patients are predictive of overall and disease free survivals.

For that purpose, 201 newly diagnosed AML patients treated intensively in the 25 centres of the French Innovative Leukemia Organisation (FILO) will be included in the FLAMVAL study.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Strasbourg University Hospital, Strasbourg, Bas-Rhin, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Confirm that the combination of the kinetic profile of FLT3L plasma levels and the IL-6 plasma level at day22 during induction in AML patients is predictive of overall survival.

    Time frame: 2 years

    time from day 1 of induction to the date of death or of last follow-up

  2. Confirm that the combination of the kinetic profile of FLT3L plasma levels and the IL-6 plasma level at day22 during induction in AML patients is predictive of overall survival.

    Time frame: 2 years

    serum FL concentration is measured at day 1, 8, 15 et 22 of induction by ELISA

  3. Confirm that the combination of the kinetic profile of FLT3L plasma levels and the IL-6 plasma level at day22 during induction in AML patients is predictive of overall survival.

    Time frame: 2 years

    level of IL-6 at day 22 has been also shown to have prognostic impact for FLD/FLI patients

Secondary outcomes

  1. Confirm that the new FL/IL6 risk-model predicts leukemia free survival in first-line AML patients.

    Time frame: 2 years

    Progression-free survival (PFS): time from day 1 of induction to refractory disease or relapse censored at the date of death or last follow-up

  2. Compare the prognostic impact of the new FL/IL6 risk-model with the impact of other parameters known to predict outcome in AML

    Time frame: 2 years

    Refractory status after induction

  3. Study the impact of the new FL/IL6 risk-model in FLT3 ITD or TKD patients receiving or not FLT3 inhibitors

    Time frame: 2 years

    cytokines plasma levels

  4. Study Immune reconstitution during induction

    Time frame: 2 years

    By flow cytometry

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: FLAMVAL

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 24, 2020
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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