Personalized dosing of azacytidine for patients with blood cancers
Involvement of CDA and/or dCK Metabolizing Enzymes in the Response to Azacytidine Treatment of Patients With Hematologic Malignancies
This study is testing if adjusting the dose of azacytidine based on patients' genetic information can help people with blood cancers like acute myeloid leukemia and myelodysplastic syndromes get better results with fewer side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Marseille) |
| Trial ID | NCT06886425 on ClinicalTrials.gov |
What this trial studies
This study aims to personalize the dosing of azacytidine, a standard treatment for acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), based on individual pharmacogenetic data. Currently, doses are adjusted after observing toxicity, but this study proposes to adjust doses beforehand to optimize treatment efficacy. Patients will undergo genetic and pharmacokinetic assessments to tailor their azacytidine dosage. The goal is to improve treatment outcomes by minimizing side effects and enhancing therapeutic effectiveness.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a diagnosis of acute myeloid leukemia or myelodysplastic syndrome who can provide consent for genetic analysis.
Not a fit: Patients who are pregnant, under guardianship, or currently participating in another research project may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and safer treatment regimens for patients with AML and MDS.
How similar studies have performed: While personalized medicine in oncology is a growing field, this specific approach to dose adjustment based on pharmacogenetics is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years of age * Patients with acute myeloid leukemia * Patient with myelodysplastic syndrome * Person who has given non-opposition * Patient who has signed an authorization to perform a constitutional genetic analysis (in the context of care) * Need for effective contraception in patients of childbearing age Exclusion Criteria: * Failure to obtain non-opposition * Adults under guardianship or safeguard of justice * Persons deprived of their liberty * Patient participating in another research project * Pregnancy in progress
Where this trial is running
Marseille
- Hôpital de la Conception — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Geoffroy Venton
- Email: promotion.interne@ap-hm.fr
- Phone: 0491435817
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.