Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04641910
Status:
RECRUITING
Last Update Posted:
2021-08-26
First Post:
2020-11-18
Brief Title:
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
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FLAMVAL
Brief Summary:
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 n26 good-risk ii increase from D1 to D15 then decrease at D22 FLD group n22 intermediate-risk and iii stagnation of low levels 1000 pgmL FLL group n14 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 FLAMFLAL 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 155 pgmL was associated with outcome allowing to distinguish between higher and lower survivals within the combined FLIFLD sub-group
A new prognostic risk-stratification can thus be proposed as follows FLIFLD with IL-6 155 pgmL favorable FLIFLD with IL-6 155 pgmL 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 ie 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
Because serum samples from this previous study called the FLAMFLAL 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 155 pgmL was associated with outcome allowing to distinguish between higher and lower survivals within the combined FLIFLD sub-group
A new prognostic risk-stratification can thus be proposed as follows FLIFLD with IL-6 155 pgmL favorable FLIFLD with IL-6 155 pgmL 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 ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None