Clinical trial · Interventional
Interest of a Therapeutic Follow-up of the Cytarabine in the Acute Myeloid Leukaemia: Is There Constitutional Biomarkers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this open-label, single-center, non-randomized patients with AML (Acute Myeloid Leukemia) and receiving all induction chemotherapy and consolidation consisting of cytarabine under the care usual for this pathology, will be included. Each patient will be followed and for the development of toxicities, treatment response and progression-free survival. In addition to the usual care set out above, each patient will undergo a series of constitutional genetic investigations conducted by NGS on markers related to pharmacokinetics cytarabine. Another set of blood samples will also calculate, according to a Bayesian approach, individual pharmacokinetics of cytarabine and its metabolite, arabinosine-uracil. This study should allow the correlation between pharmacogenetics and patient plasma exposure, that would eventually balance improved efficacy / toxicity of this molecule through a customization regimens, achieved so far on a empirical basis. If validation of our data, a dosage of therapeutic pre CDA could help in predicting pharmacodynamics of cytarabine individual dose adjustment, as is done for the 5-FU and DPD.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sampling | Biological | — | UNRESOLVED |
| Genetic analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients treated with Cytarabine
- interventionNames
- Biological: Blood sampling
- Genetic: Genetic analysis
Primary outcomes (2)
- measure
- Measurements of circulating levels of cytarabine and its metabolites.
- timeFrame
- 6 months maximum
- measure
- Assessment of genetic polymorphism of somatic Cytidine Deaminase (CDA) and Déoxycitidine Kinase (dCK).
- timeFrame
- 6 months maximum
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient aged over 18 years old * Patient with acute myeloid leukemia * Patient treated with cytarabine * Patient having signed an informed consent form * Patient having signed an authorization to practice a constitutional genetic analysis * Need for effective contraception in patients of childbearing age. * Patient affiliated to a social security scheme Exclusion Criteria * Not obtaining free, informed and signed consent * Patient participating in another biomedical research * Pregnant patients
References
Publications (0)
Data not yet available