Status:
RECRUITING
Single-cell Dynamic Profiling in Adults With Newly Diagnosed Acute Myeloid Leukemia Treated With Intensive Chemotherapy. A THEMA Study"
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
The detailed molecular and cellular mechanisms underpinning the clinical activity of most chemotherapies in cancers remain incompletely understood. Understanding how these drugs really act is a prereq...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 26 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 26 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05304156
Start Date
April 26 2022
End Date
May 26 2026
Last Update
May 29 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Avicenne
Bobigny, France
2
Hôpital Saint Louis
Paris, France