Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06439199

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location status: Recruiting

Location contact

Alice GARNIER, PH

CONTACT

[email protected]

33 2 44 76 80 81

About this study

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 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

    Time frame: 2 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Alice GARNIER, PH

CONTACT

[email protected]

33 2 44 76 80 81

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study 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)

Acronym: CYTOK-AZA

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2024
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.