Profiling blood and bone marrow in adults with newly diagnosed acute myeloid leukemia during chemotherapy
Single-cell Dynamic Profiling in Adults With Newly Diagnosed Acute Myeloid Leukemia Treated With Intensive Chemotherapy. A THEMA Study"
This study is trying to see how chemotherapy affects blood and bone marrow in adults with newly diagnosed acute myeloid leukemia to help improve treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | gemtuzumab, chemotherapy |
| Locations | 2 sites (Bobigny and 1 other locations) |
| Trial ID | NCT05304156 on ClinicalTrials.gov |
What this trial studies
This observational study aims to understand the molecular and cellular mechanisms of chemotherapy in adults with newly diagnosed acute myeloid leukemia (AML). By sequentially sampling peripheral blood and performing early bone marrow reassessments during the first course of intensive chemotherapy, researchers will utilize single-cell RNA sequencing and multiparameter flow cytometry. The goal is to correlate the dynamic changes in cancer cell phenotypes with clinical outcomes such as remission achievement and relapse-free survival. This approach may provide insights into optimizing chemotherapy treatments for AML patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed acute myeloid leukemia who are eligible for intensive chemotherapy.
Not a fit: Patients who have received prior treatment for AML or those with severe health issues preventing intensive chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved chemotherapy strategies and better outcomes for patients with acute myeloid leukemia.
How similar studies have performed: While the specific approach of this study is novel, similar studies have shown promise in understanding chemotherapy responses in other cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * aged ≥18 years old, * have a newly diagnosed AML according to WHO criteria o patients with AML related to prior chemotherapy or radiotherapy for another cancer will be eligible, * have signed the informed consent form of the e-THEMA observatory trial * have ≥10% blasts (blasts+myeloblasts) on the peripheral blood smear at screening, * have ≥20% blasts on the bone marrow smear at screening, * have not received any treatment for AML except for hydroxyurea and/or 6-mercaptopurine and steroids o Patients having previous treatments for antecedent myeloid neoplasms including hypomethylating agents remain eligible, * Eligible to intensive chemotherapy, due to general health status, * ECOG performance status ≤ 2, * Patient is planned to receive anthracycline (daunorubicin \[DNR\] or idarubicine \[IDA\]) - cytarabine 7+3 with or without gemtuzumab ozogamycin (GO) or midostaurine, or CPX-351 as first induction course, * Weighing 50 kg or more (compliance to Loi Jardé for PB sampling), * Written informed consent obtained prior to any screening procedures, * Eligible for National Health Insurance in France. Exclusion Criteria: * Suspected or proven acute promyelocytic leukemia based on morphology, karyotype or molecular assay, * Failure to perform bone marrow aspiration at diagnosis, * Unstable angina, New York Heart Association (NYHA) class 3 or 4 congestive heart failure, * Prior anthracycline exposure more than 360 mg/m², * Previous therapy for AML with any other investigational agent or cytotoxic drug, within 28 days before starting treatment. Only hydroxyurea is permitted for the control of blood counts. Treatments for an antecedent myeloid neoplasm (MDS or MPN) are not considered as exclusion criteria. * Women who are pregnant or breastfeeding. * Any of concurrent severe and/or uncontrolled medical condition, which could compromise participation in the study. * Enrolment in a clinical trial which could compromise participation in the study.
Where this trial is running
Bobigny and 1 other locations
- Hôpital Avicenne — Bobigny, France (Recruiting)
- Hôpital Saint Louis — Paris, France (Recruiting)
Study contacts
- Study coordinator: Raphael ITZYKSON
- Email: raphael.itzykson@aphp.fr
- Phone: +33171207031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.