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
Study ID
NCT06439199
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jun 3, 2024
Start date
Sep 23, 2024
Status verified
Apr 2026
Primary completion
Jul 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Evaluation of cytokine profiles (Flt3-L, IL (Interleukin) 1beta, IL6, IL8/CXCL8, IL10, IL15, IL17A, IL17E, IL17-F, IL18, GM-CSF, TNFalpha) in patients treated non-intensively for AML, SMD-HR or an LMMC. [ Time Frame: 2 years ]

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