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Interest of a Therapeutic Follow-up of the Cytarabine in the Acute Myeloid Leukaemia: Is There Constitutional Biomarkers

NCT03337516 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-11-09

No results posted yet for this study

Summary

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

Interventions

BIOLOGICAL

Blood sampling

Blood sampling in order to assess cytarabine pharmacokinetics

GENETIC

Genetic analysis

Genetic analysis in order to determine genetic polyporphism of Deoxycytidine Kinase and Cytidine Deaminase

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Jean-Olivier ARNAUD · Assistance Publique- Hôpitaux de Marseille

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-21
Primary Completion
2017-12-21
Completion
2018-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03337516 on ClinicalTrials.gov