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

Primary Purpose

Myeloid Leukemia, Myelodysplastic Syndromes

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
azacytidine
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myeloid Leukemia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique - Hopitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patient suffering of MDS or Myeloid leukemia

Arm Description

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

Outcomes

Primary Outcome Measures

Number of survival without progress of the disease

Secondary Outcome Measures

Full Information

First Posted
May 28, 2015
Last Updated
July 2, 2015
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02489929
Brief Title
Evaluation of Cytidine Deaminase for Patient Suffering of a Myelodysplastic Syndrom or an AML Treated by Azacytidine
Official Title
Evaluation of Cytidine Deaminase for Patient Suffering of a Myelodysplasic Syndrom or an Acute Myeloid Leukemia and Treated by Azacytidine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloid Leukemia, Myelodysplastic Syndromes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patient suffering of MDS or Myeloid leukemia
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
blood samples
Intervention Description
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
Drug
Intervention Name(s)
azacytidine
Primary Outcome Measure Information:
Title
Number of survival without progress of the disease
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra GIULIANI
Phone
+33491382870
Email
agiuliani@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Regis COSTELLO, MD
Organizational Affiliation
AP-HM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique - Hopitaux de Marseille
City
Marseille
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regis Costello
Email
regis.costello@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Regis Costello

12. IPD Sharing Statement

Learn more about this trial

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

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