Acute Myeloid LeukemiaOXYLAMNCT02602587
Study of Dendrogenin A / Oxysterols Balance Between Healthy Volunteers and Acute Myeloid Leukemia Patients
A study testing Blood sample and Bone marrow sample in people with Acute Myeloid Leukemia, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Blood sample and Bone marrow sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2014to 20 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Blood sample, Bone marrow sample
- Keywords
- acute myeloid leukemia, Dendrogenin A, 5,6-cholesterol epoxide, 6-oxo-cholestane-3beta, 5alpha-diol, cholesterol epoxide hydrolase, oxysterols
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
additional samples of blood in acts planned in the prognostic or follow-up protocols.
Bone marrow sampleBiological
additional bone marrow sample in acts planned in the prognostic or follow-up protocols.
| Study group | Role | What they receive |
|---|---|---|
| blood samples and bone marrow samples | Experimental | 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. Receives: Biological: Blood sample; Biological: Bone marrow sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 1
Secondary outcomes (1)
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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study start25 Nov 2014
- Primary completion20 Nov 2018
- Study completion20 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian RECHER, Doctor, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602587
- Sponsor's protocol ID
- 14 7166 03
- Acronym
- OXYLAM
- Status last verified
- May 2019
- First submitted
- 2 Nov 2015
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02602587
- Acronym / sponsor ID
- OXYLAM / 14 7166 03
- Conditions
- Acute Myeloid Leukemia
- Keywords
- acute myeloid leukemia, Dendrogenin A, 5,6-cholesterol epoxide, 6-oxo-cholestane-3beta, 5alpha-diol, cholesterol epoxide hydrolase, oxysterols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 25 Nov 2014 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood samples and bone marrow samples | Experimental | Biological: Blood sample, Biological: Bone marrow sampleThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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
Key exclusion criteria (11 listed)
- 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.
- Patients having received any anti-AML treatment with the exception of oral hydroxyurea.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleadditional samples of blood in acts planned in the prognostic or follow-up protocols. | Biological | blood samples and bone marrow samples |
| Bone marrow sampleadditional bone marrow sample in acts planned in the prognostic or follow-up protocols. | Biological | blood samples and bone marrow samples |
Primary outcome
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
1 secondary outcome
50 percent inhibitory concentration
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian RECHER, Doctor principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample and Bone marrow sample in people with Acute Myeloid Leukemia, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of dendrogenin A between patients and healthy donors (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.