Clinical trial · Interventional
Study of Dendrogenin A / Oxysterols Balance Between Healthy Volunteers and Acute Myeloid Leukemia Patients
Study of Dendrogenin A / Oxysterols Balance Between Healthy Volunteers and Acute Myeloid Leukemia Patients. Modulations of the Balance During Cytarabine/Anthracycline Treatment - OxyLAM
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Biological | — | UNRESOLVED |
| Bone marrow sample | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- blood samples and bone marrow samples
- 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.
- interventionNames
- Biological: Blood sample
- Biological: Bone marrow sample
Primary outcomes (1)
- measure
- Difference of dendrogenin A between patients and healthy donors
- timeFrame
- day 1
- description
- Comparison of levels of Dendrogenin A, oxysterols and related proteins between healthy volunteers and AML patients
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
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