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

May 10, 2019 updated by: University Hospital, Toulouse

Study of Dendrogenin A / Oxysterols Balance Between Healthy Volunteers and Acute Myeloid Leukemia Patients. Modulations of the Balance During Cytarabine/Anthracycline Treatment - OxyLAM

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France
        • CHU Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: blood samples and bone marrow samples
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.
Biological: Blood sample
additional samples of blood in acts planned in the prognostic or follow-up protocols.
Biological: Bone marrow sample
additional bone marrow sample in acts planned in the prognostic or follow-up protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of dendrogenin A between patients and healthy donors
Time Frame: day 1
Comparison of levels of Dendrogenin A, oxysterols and related proteins between healthy volunteers and AML patients
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
50 percent inhibitory concentration
Time Frame: day 1
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.
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Christian RECHER, Doctor, CHU Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2014

Primary Completion (Actual)

November 20, 2018

Study Completion (Actual)

November 20, 2018

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Actual)

May 13, 2019

Last Update Submitted That Met QC Criteria

May 10, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14 7166 03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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