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

NCT03337516 | Unknown

• 2 other identifiers: 2017-022017-A00070-53
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

• Measurements of circulating levels of cytarabine and its metabolites.

  6 months maximum

• Assessment of genetic polymorphism of somatic Cytidine Deaminase (CDA) and Déoxycitidine Kinase (dCK).

  6 months maximum

Study Arms (1)

Patients treated with Cytarabine

EXPERIMENTAL

Biological: Blood sampling; Genetic: Genetic analysis

Interventions

Blood sampling BIOLOGICAL

Blood sampling in order to assess cytarabine pharmacokinetics

Patients treated with Cytarabine

Genetic analysis GENETIC

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

Patients treated with Cytarabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not obtaining free, informed and signed consent
• Patient participating in another biomedical research
• Pregnant patients

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique - Hopitaux de Marseille

Marseille, France

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Blood Specimen Collection; Genetic Testing

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Jean-Olivier ARNAUD

  Assistance Publique- Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Régis COSTELLO, MD-PhD

CONTACT

regis.costello@ap-hm.fr

Camille DELANNOY

CONTACT

drci@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 9, 2017
• Study Start: June 21, 2017
• Primary Completion: December 21, 2017
• Study Completion: December 31, 2018
• Last Updated: November 9, 2017

Record last verified: 2017-11

Locations

FR (1)