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Study of Dendrogenin A / Oxysterols Balance Between Healthy Volunteers and Acute Myeloid Leukemia Patients (OXYLAM)

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Bone marrow sample
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Acute Myeloid Leukemia focused on measuring acute myeloid leukemia, Dendrogenin A, 5,6-cholesterol epoxide, 6-oxo-cholestane-3beta, 5alpha-diol, cholesterol epoxide hydrolase, oxysterols

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Men or women of 18 years old or older
  • Informed consent obtained and signed before any specific procedure in the study

  • Patient member in a national insurance scheme

    * For patients with AML

  • Men or women with a non promyelocytic acute myeloid leukemia as defined by WHO criteria and with at least 20% leukemic cells in blood at diagnosis
  • for which treatment combining cytarabine and daunorubicin or idarubicin is retained

  • WHO performance status ≤ 2

    • for healthy volunteers Criteria of eligibility for blood or bone marrow donation according to French Blood Institution

Exclusion criteria:

  • Pregnant women or nursing mothers cannot participate in the study.
  • Patients under legal guardianship.
  • Any other medical or psychiatric condition or laboratory abnormality severe, acute or chronic making the inclusion of the patient in the study inappropriate in the opinion of the investigator.

  • Patient unable to follow procedures, visits, examinations described in the study.

    * For patients with AML :

  • Patients having received any anti-AML treatment with the exception of oral hydroxyurea.

  • Patients for which a treatment different from the combination cytarabine+anthracycline has been selected

    * For healthy volunteers

  • Criteria of ineligibility for blood donation according to EFS (French Blood Institution)
  • For bone marrow : heart disease, high blood pressure, respiratory diseases, diseases of the nervous system history of cancers, diseases metabolic (diabetes, liver failure), history of recurring phlebitis or pulmonary embolism, disabling lumbar problems, neuromuscular diseases, angioedema, significant overweight,.
  • Any long term treatment, except contraception

Sites / Locations

  • Chu Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

blood samples and bone marrow samples

Arm Description

The patients included in this study will be processed according to the standard treatment in force for their disease. This study does not in any way interfere with this treatment regimen, and is only based on additional samples of blood and bone marrow in acts planned in the prognostic or follow-up protocols. Treatment shall start within the 15 days following inclusion and first sampling.

Outcomes

Primary Outcome Measures

Difference of dendrogenin A between patients and healthy donors
Comparison of levels of Dendrogenin A, oxysterols and related proteins between healthy volunteers and AML patients

Secondary Outcome Measures

50 percent inhibitory concentration
50 percent inhibitory concentration (evaluated by the rate of dead cells determined by a staining exclusion test and / or by flow cytometry) to assess the in vitro efficacy of Dendrogenin A in AML samples.

Full Information

First Posted
November 2, 2015
Last Updated
May 10, 2019
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02602587
Brief Title
Study of Dendrogenin A / Oxysterols Balance Between Healthy Volunteers and Acute Myeloid Leukemia Patients
Acronym
OXYLAM
Official Title
Study of Dendrogenin A / Oxysterols Balance Between Healthy Volunteers and Acute Myeloid Leukemia Patients. Modulations of the Balance During Cytarabine/Anthracycline Treatment - OxyLAM
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 25, 2014 (Actual)
Primary Completion Date
November 20, 2018 (Actual)
Study Completion Date
November 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Dendrogenin A is present in mammals normal tissues and fluids, notably blood. It is down-represented or absent in cancer cell lines and tumors. In the opposite, OCDO is accumulated in cancerous conditions and virtually absent of normal tissues. This study will try to determine modulations of these oxysterols and protein involved in their metabolism between Acute myeloid leukemia (AML) patient samples and normal blood or marrow, for evaluation of these markers as companion biomarkers for Dendrogenin A treatment.
Detailed Description
Background : Acute myeloid leukemia is an unmet medical need since 5-year overall survival is 40-50% in younger adults and 10-15% in elderly. Dendrogenin A is a natural novel anticancer agent showing potent antileukemic activity which is under-represented in tumors. Dendrogenin A inhibits Cholesterol epoxide hydrolase and so modulates levels of substrates and products of this enzymatic complex. Purpose : This is a biomedical study of interventional type which includes 30 patients and 30 blood samples as well as 5 marrow samples from healthy donors. It will last 24 month, 8 months recruiting and 16 months follow-up. Patients with acute myeloid leukemia for which an indication of chemotherapy treatment is retained will be enrolled in this study. This study will compare oxysterols (Dendrogenin A, 6-oxo-cholestane-3beta,5alpha-diol - OCDO) and related proteins as biomarkers of the disease between the two populations. Interventions : The patients included in this study will be processed according to the standard treatment in force for their disease. This study does not in any way interfere with this treatment regimen, and is only based on additional samples of blood and bone marrow in acts planned in the prognostic or follow-up protocols. Treatment shall start within the 15 days following inclusion and first sampling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
acute myeloid leukemia, Dendrogenin A, 5,6-cholesterol epoxide, 6-oxo-cholestane-3beta, 5alpha-diol, cholesterol epoxide hydrolase, oxysterols

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
blood samples and bone marrow samples
Arm Type
Experimental
Arm Description
The patients included in this study will be processed according to the standard treatment in force for their disease. This study does not in any way interfere with this treatment regimen, and is only based on additional samples of blood and bone marrow in acts planned in the prognostic or follow-up protocols. Treatment shall start within the 15 days following inclusion and first sampling.
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
additional samples of blood in acts planned in the prognostic or follow-up protocols.
Intervention Type
Biological
Intervention Name(s)
Bone marrow sample
Intervention Description
additional bone marrow sample in acts planned in the prognostic or follow-up protocols.
Primary Outcome Measure Information:
Title
Difference of dendrogenin A between patients and healthy donors
Description
Comparison of levels of Dendrogenin A, oxysterols and related proteins between healthy volunteers and AML patients
Time Frame
day 1
Secondary Outcome Measure Information:
Title
50 percent inhibitory concentration
Description
50 percent inhibitory concentration (evaluated by the rate of dead cells determined by a staining exclusion test and / or by flow cytometry) to assess the in vitro efficacy of Dendrogenin A in AML samples.
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men or women of 18 years old or older Informed consent obtained and signed before any specific procedure in the study Patient member in a national insurance scheme * For patients with AML Men or women with a non promyelocytic acute myeloid leukemia as defined by WHO criteria and with at least 20% leukemic cells in blood at diagnosis for which treatment combining cytarabine and daunorubicin or idarubicin is retained WHO performance status ≤ 2 for healthy volunteers Criteria of eligibility for blood or bone marrow donation according to French Blood Institution Exclusion criteria: Pregnant women or nursing mothers cannot participate in the study. Patients under legal guardianship. Any other medical or psychiatric condition or laboratory abnormality severe, acute or chronic making the inclusion of the patient in the study inappropriate in the opinion of the investigator. Patient unable to follow procedures, visits, examinations described in the study. * For patients with AML : Patients having received any anti-AML treatment with the exception of oral hydroxyurea. Patients for which a treatment different from the combination cytarabine+anthracycline has been selected * For healthy volunteers Criteria of ineligibility for blood donation according to EFS (French Blood Institution) For bone marrow : heart disease, high blood pressure, respiratory diseases, diseases of the nervous system history of cancers, diseases metabolic (diabetes, liver failure), history of recurring phlebitis or pulmonary embolism, disabling lumbar problems, neuromuscular diseases, angioedema, significant overweight,. Any long term treatment, except contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian RECHER, Doctor
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Toulouse
City
Toulouse
Country
France

12. IPD Sharing Statement

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Study of Dendrogenin A / Oxysterols Balance Between Healthy Volunteers and Acute Myeloid Leukemia Patients

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