Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06439199
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-02-09
Brief Title:
Biological Prospective Study Evaluating the Dosage of Plasma Cytokines Including the FLT3 Ligand and IL6 of Patients Treated With Non-intensive Chemotherapy
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Single-center Biological Uncontrolled Prospective Study Evaluating the Dosage of Plasma Cytokines Including the FLT3 FMS-like Tyrosine Kinase 3 Ligand and IL6 With a View to Making a First Estimate of Their Prognostic Value on the Outcome of Patients Treated With Non-intensive Chemotherapy Such as Azacytidine for Acute Myelogenous Leukemia AML High Risk Myelodysplastic Syndrome HR-MDS or Chronic Myelomonocytic Leukemia CMML
Status:
RECRUITING
Status Verified Date:
2024-09
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:
CYTOK-AZA
Brief Summary:
There are 2 possible treatments for the treatment of Acute Myelogenous Leukemia AML high-risk myelodysplastic syndromes HR-MDS or chronic myelomonocytic leukemia CMML intensive curative chemotherapy and for over-aged or co-morbid patients non-intensive palliative chemotherapy with a hypomethylating agent Azacytidine associated or not with venetoclax
Pro-inflammatory cytokines and in particular IL-6 Interleukin 6 seem to play a key role in the chemoresistance of solid cancers and AML it would be associated with a poor prognosis of AML would promote the proliferation of leukemic blasts and would promote the progression of MDS to AML
In AML treated with intensive chemotherapy researchers demonstrated that a particular kinetic profile of the FLT3 ligand and IL6 at day 22 could very significantly predict the survival of patients with AML
It therefore seems interesting to study the plasma cytokine profiles in patients with AML HR-MDS or CMML treated non-intensively and to see if researchers observe the same prognostic correlation as during intensive chemotherapy
Pro-inflammatory cytokines and in particular IL-6 Interleukin 6 seem to play a key role in the chemoresistance of solid cancers and AML it would be associated with a poor prognosis of AML would promote the proliferation of leukemic blasts and would promote the progression of MDS to AML
In AML treated with intensive chemotherapy researchers demonstrated that a particular kinetic profile of the FLT3 ligand and IL6 at day 22 could very significantly predict the survival of patients with AML
It therefore seems interesting to study the plasma cytokine profiles in patients with AML HR-MDS or CMML treated non-intensively and to see if researchers observe the same prognostic correlation as during intensive chemotherapy
Detailed Description:
Patients will be divided into 2 groups treated according to a non-intensive chemotherapy
Group 1 40 patients treated with Azacytidine and Venetoclax - another molecule according to the following schedule
Azacytidine 75 mgm² D1 to D7 SC
Venetoclax 400 mgday orally in 1 dose between 14 and 28 days per cycle The cycles will be 28 days long and will be carried out until relapse or death Cytokine assays will be carried out on D1 D8 D15 and D22 of each cycle for 2 cycles
Group 2 20 patients treated with Azacytidine - another molecule according to the following schedule
Azacytidine 75 mgm² D1 to D7 SC The cycles will be 28 days long and will be carried out until relapse or death The cytokine assays will be carried out on D1 D8 D15 and D22 of each cycle for 3 cycles
The duration of follow-up for a patient is 12 months from day 1 of the first cycle
Group 1 40 patients treated with Azacytidine and Venetoclax - another molecule according to the following schedule
Azacytidine 75 mgm² D1 to D7 SC
Venetoclax 400 mgday orally in 1 dose between 14 and 28 days per cycle The cycles will be 28 days long and will be carried out until relapse or death Cytokine assays will be carried out on D1 D8 D15 and D22 of each cycle for 2 cycles
Group 2 20 patients treated with Azacytidine - another molecule according to the following schedule
Azacytidine 75 mgm² D1 to D7 SC The cycles will be 28 days long and will be carried out until relapse or death The cytokine assays will be carried out on D1 D8 D15 and D22 of each cycle for 3 cycles
The duration of follow-up for a patient is 12 months from day 1 of the first cycle
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