Biological, Prospective Study Evaluating the Dosage of Plasma Cytokines Including the FLT3 Ligand and IL6 of Patients Treated With Non-intensive Chemotherapy
NCT ID: NCT06439199
Last Updated: 2024-09-27
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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RECRUITING
60 participants
OBSERVATIONAL
2024-09-23
2026-12-15
Brief Summary
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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.
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Detailed Description
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Group 1 : 40 patients treated with Azacytidine and Venetoclax +/- another molecule according to the following schedule:
* Azacytidine 75 mg/m² D1 to D7 SC
* Venetoclax: 400 mg/day 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 mg/m² 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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Azacytidine and Venetoclax
40 patients treated with Azacytidine and Venetoclax +/- another molecule according to the following schedule:
* Azacytidine 75 mg/m² D1 to D7 SC
* Venetoclax: 400 mg/day 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.
No interventions assigned to this group
Azacytidine
20 patients treated with Azacytidine +/- another molecule according to the following schedule:
• Azacytidine 75 mg/m² 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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* AML or SMD-HR or CMML in first line or in relapse receiving a hypomethylating agent +/- another molecule or a hypomethylating agent in combination with venetoclax +/- another molecule.
* Patient having agreed to participate in the study (information note signature) and having signed the biocollection consent
Exclusion Criteria
* Pregnant women or patient unable to take contraception in case of fertility
* Breastfeeding women
* Minors
* Adults under guardianship, curators or safeguard of justice
18 Years
99 Years
ALL
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Nantes University Hospital
OTHER
Responsible Party
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Locations
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Nantes University Hospital
Nantes, Loire-Atlantique, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RC23_0332
Identifier Type: -
Identifier Source: org_study_id
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