Evaluation of Cytidine Deaminase for Patient Suffering of a Myelodysplastic Syndrom or an AML Treated by Azacytidine

NCT ID: NCT02489929

Last Updated: 2015-07-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2019-03-31

Brief Summary

Myelodysplastic syndrome (MDS) is a group of medical conditions derived from progressive bone marrow failure that result in ineffective production of blood cells. Depending on the severity, MDS reduces the quality of life to the point of being life-threatening. There is a probability of death at all stages of the disease, due to complications and co-morbidities, with progression to acute myeloid leukemia (AML) being the worst evolution. Azacytidine is a nucleosidic analog with original epigenetic mechanism of action that is widely used for treating a variety of myelodysplasic syndromes. Although generally well tolerated, severe and sometimes life-threatening toxicities were unexpectedly observed in some patients. Genetic polymorphism affecting cytidine deaminase (CDA), the liver enzyme responsible for azacytidine detoxification step, could be responsible for poor clinical outcome due to on the one hand to severe toxicities in deficient patients, and on the other hand on treatment failure in ultrametabolizer patients.This clinical study aims at correlating the values in CDA levels with the risk of drug-related toxicities and to the clinical response to azacytidine treatment.

Conditions

Myeloid Leukemia; Myelodysplastic Syndromes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patient suffering of MDS or Myeloid leukemia

The patients suffering of MDS or Acute myeloid leukemia will be the object of 8 sampling of blood (on tube EDTA) distributed as this: the first day of the usual treatment (azacytidine) at T0, T30 MIN, T60 MIN, T90 MIN, T120 MIN, then a second series of taking in the 5th day of treatment at T0, T30 MIN, T90 MIN to determine cytidine deaminase (CDA) activities by following its plasmatic dosage

Group Type: EXPERIMENTAL

blood samples

Intervention Type: OTHER

This clinical study aims at correlating the values in CDA levels with the risk of drug-related toxicities and to the clinical response to azacytidine treatment for patient suffering of MDS or Myeloid leukemia

azacytidine

Intervention Type: DRUG

Interventions

blood samples

This clinical study aims at correlating the values in CDA levels with the risk of drug-related toxicities and to the clinical response to azacytidine treatment for patient suffering of MDS or Myeloid leukemia

Intervention Type: OTHER

azacytidine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The patients have to be capable of submitting themselves at the rate of the visits, in the plan of treatmen, in the balance assessments of laboratory and other procedures of the study.
• Patient treated by azacytidine

Exclusion Criteria

• Patients having an infection unchecked who could compromise the participation in the study
• Patients having other grave and/or unchecked concomitant diseases which could compromise the participation in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Regis COSTELLO, MD

Role: PRINCIPAL_INVESTIGATOR

AP-HM

Locations

Assistance Publique - Hopitaux de Marseille

Marseille, , France

Countries

France

Central Contacts

Alexandra GIULIANI

Role: CONTACT

agiuliani@ap-hm.fr

+33491382870

Facility Contacts

Regis Costello

Role: primary

regis.costello@ap-hm.fr

Other Identifiers

2014-A01797-40

Identifier Type: -

Identifier Source: org_study_id