Actively Recruiting
Involvement of CDA and/or dCK Metabolizing Enzymes in the Response to Azacytidine Treatment of Patients With Hematologic Malignancies
Led by Assistance Publique Hopitaux De Marseille · Updated on 2025-03-20
70
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how to personalize the dosage of azacytidine, a common treatment for patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The study aims to determine if adjusting doses based on each patient's genetic makeup and individual characteristics can improve treatment outcomes and reduce toxicity. This is an open-label, non-randomized study involving patients receiving azacytidine as part of their standard care. Participants will receive azacytidine at the standard dose of 75 mg/m² daily for 7 days, repeated every 28 days. Alongside this, the study includes genetic testing using next-generation sequencing (NGS) to analyze enzymes affecting azacytidine metabolism (CDA and dCK). Blood samples will be collected at multiple treatment cycles to measure drug levels and enzyme activity, using mathematical models to predict and personalize dosing. Throughout the study, patients will be monitored for treatment response, progression-free survival, and toxicities using standard criteria. Blood samples will be taken before and after treatment cycles to assess drug exposure and genetic markers. The study will last approximately two years, during which researchers will evaluate how genetics impact drug levels and side effects to potentially improve dosing strategies in the future.
CONDITIONS
Brief Title
Involvement of CDA and/or dCK Metabolizing Enzymes in the Response to Azacytidine Treatment of Patients With Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age
- Diagnosis of acute myeloid leukemia
- Diagnosis of myelodysplastic syndrome
- Provided non-opposition consent
- Signed authorization for constitutional genetic analysis
- Use of effective contraception for patients of childbearing age
You will not qualify if you...
- Failure to provide non-opposition consent
- Adults under guardianship or legal protection
- Persons deprived of liberty
- Participation in another research project
- Current pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies by individual treatment duration
Participants receive subcutaneous administration of azacytidine during treatment phases called cures. Blood sampling for genetic and pharmacokinetic studies is conducted before starting and after completing treatment at specified cures.
Blood sampling at Cure 1 before starting treatment, Cure 3 before starting treatment, and Cure 6 after completion of treatment; pharmacokinetic sampling includes 5 samples after azacytidine administration during induction phases at Cures 1, 3, and 6
Duration - Up to 2 years
Participants are monitored for plasma levels of azacytidine and phenotypic activity of cytidine deaminase for up to approximately 2 years after treatment.
Visits occur through study completion for ongoing plasma and phenotypic activity assessments
Trial Site Locations
Total: 1 location
1
Hôpital de la Conception
Marseille, France, 13005
Actively Recruiting
Research Team
G
Geoffroy Venton
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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