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
NCT ID: NCT04641910
Last Updated: 2021-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
201 participants
OBSERVATIONAL
2021-06-08
2025-06-08
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* Adults under guardianship, subjects under protection.
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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Strasbourg University Hospital
Strasbourg, Bas-Rhin, France
Paoli-Calmette Institute
Marseille, Bouches-du-Rhône, France
Besançon University Hospital
Besançon, Doubs, France
Brest University Hospital
Brest, Finistère, France
Nîmes University Hospital
Nîmes, Gard, France
Bordeaux University Hospital
Bordeaux, Gironde, France
Mulhouse Hospital Center
Mulhouse, Haut-Rhin, France
Toulouse University Cancer Institute
Toulouse, Haute-Garonne, France
Béziers Hospital Center
Béziers, Hérault, France
Montpellier University Hospital
Montpellier, Hérault, France
Rennes University Hospital
Rennes, Ille-et-Vilaine, France
Tours University Hospital
Tours, Indre-et-Loire, France
Grenoble University Hospital
Grenoble, Isère, France
Nantes University Hospital
Nantes, Loire-Atlantique, France
Angers University Hospital
Angers, Maine-et-Loire, France
Reims University Hospital
Reims, Marne, France
Nancy University Hospital
Nancy, Meurthe-et-Moselle, France
Mercy Regional Hospital
Metz, Moselle, France
Saint-Etienne University Hospital
Saint-Étienne-de-Montluc, Pays de la Loire Region, France
Clermont-Ferrand University Hospital
Clermont-Ferrand, Puy-de-Dôme, France
Basque coast hospital center
Bayonne, Pyrénées-Atlantiques, France
Saint-Jean Hospital Center
Perpignan, Pyrénées-Orientales, France
Lyon University Hospital
Lyon, Rhône, France
AP-HP Cochin Hospital
Paris, , France
Poitiers University Hospital
Poitiers, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC20_0406
Identifier Type: -
Identifier Source: org_study_id
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