Acute Myeloid LeukemiaCYTOK-AZANCT06439199
Biological, Prospective Study Evaluating the Dosage of Plasma Cytokines Including the FLT3 Ligand and IL6 of Patients Treated With Non-intensive Chemotherapy
An observational study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Nantes University Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2024to 15 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Study population: 40 patients treated with Azacytidine and Venetoclax +/- another molecule and 20 patients treated with Azacytidine +/- another molecule.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes, Loire-Atlantique, 44093
Alice GARNIER, PH, 33 2 44 76 80 81, alice.garnier@chu-nantes.fr
About this study
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)
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 .
Read more
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.
Read the 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 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.
- Keywords
- Cytokine, IL 6, FLT3 Ligand, AML, CMML, HR MDS, Azacytidine
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start23 Sep 2024
- Primary completion15 Jul 2028 (estimated)
- Study completion15 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439199
- Sponsor's protocol ID
- RC23_0332
- Acronym
- CYTOK-AZA
- Status last verified
- Sep 2026
- First submitted
- 9 Feb 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06439199
- Acronym / sponsor ID
- CYTOK-AZA / RC23_0332
- Keywords
- Cytokine, IL 6, FLT3 Ligand, AML, CMML, HR MDS, Azacytidine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 15 Jul 2028 (estimated)
- Study completion
- 15 Dec 2029 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 40 patients treated with Azacytidine and Venetoclax +/- another molecule and 20 patients treated with Azacytidine +/- another molecule.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice GARNIER, PH (33 2 44 76 80 81, alice.garnier@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.