Biological, Prospective Study Evaluating the Dosage of Plasma Cytokines Including the FLT3 Ligand and IL6 of Patients Treated With Non-intensive Chemotherapy

NCT06439199 | Recruiting

• 1 other identifier: RC23_0332
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndromes; Chronic Myelomonocytic Leukemia

Keywords

Cytokine; IL 6; FLT3 Ligand; AML; CMML; HR MDS; Azacytidine

Outcome Measures

Primary Outcomes (1)

• 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.

  Determination of plasma cytokines (Flt3-L, IL1beta, IL6, IL8/CXCL8, IL10, IL15, IL17A, IL17E, IL17-F, IL18, GM-CSF (granulocyte-monocyte colony-stimulating factor, TNFalpha) by Luminex at diagnosis and during treatment of adult patients with of AML, SMD-HR (High risk myelodysplastic syndrome) or CMML(Chronic myelomonocytic leukemia) treated non-intensively

  2 years

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

40 patients treated with Azacytidine and Venetoclax +/- another molecule and 20 patients treated with Azacytidine +/- another molecule.

You may qualify if:

• Age \>=18 years
• 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

You may not qualify if:

• No social security or any other regime
• Pregnant women or patient unable to take contraception in case of fertility
• Breastfeeding women
• Minors
• Adults under guardianship, curators or safeguard of justice

Sponsors & Collaborators

• Nantes University Hospital: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

During the weekly blood samples taken in the day hospital as part of the treatment, an additional 9 ml EDTA tube will be taken, during the first 2 cycles for group 1 and during the first 3 cycles for group 2.This additional tube will be used to supply this biocollection and to promote the development of knowledge in the field of acute myeloidblastic leukemia, myelodysplasia and chronic myelomonocytic leukemia.

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Myelodysplastic-Myeloproliferative Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alice GARNIER, PH

CONTACT

33 2 44 76 80 81; alice.garnier@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: June 3, 2024
• Study Start: September 23, 2024
• Primary Completion: July 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)