Evaluating plasma cytokines in patients with certain blood cancers treated with non-intensive chemotherapy
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)
This study is trying to see if measuring certain proteins in the blood can help predict how well patients with specific blood cancers do when they receive two different types of chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nantes, Loire-Atlantique) |
| Trial ID | NCT06439199 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the plasma cytokine profiles, specifically focusing on FLT3 ligand and IL-6, in patients with Acute Myeloid Leukemia (AML), high-risk myelodysplastic syndromes (HR-MDS), or chronic myelomonocytic leukemia (CMML) who are receiving non-intensive chemotherapy. Patients will be divided into two groups: one receiving Azacytidine and Venetoclax, and the other receiving Azacytidine alone. Cytokine assays will be conducted at various intervals during treatment cycles to assess their predictive value for patient outcomes. The study will follow patients for 12 months from the start of treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with AML, HR-MDS, or CMML who are receiving non-intensive chemotherapy.
Not a fit: Patients who are pregnant, breastfeeding, or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of cytokine profiles that predict treatment responses and outcomes in patients with these blood cancers.
How similar studies have performed: While the study focuses on a specific patient population and treatment approach, similar studies have shown that cytokine profiles can be indicative of treatment outcomes in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nantes, Loire-Atlantique
- Nantes University Hospital — Nantes, Loire-Atlantique, France (Recruiting)
Study contacts
- Study coordinator: Alice GARNIER, PH
- Email: alice.garnier@chu-nantes.fr
- Phone: 33 2 44 76 80 81
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.