Status:
RECRUITING
Relation Between Venetoclax Plasma Concentration and Remission in Adults with Acute Myeloid Leukemia (PREDICLAX)
Lead Sponsor:
University Hospital, Caen
Conditions:
Adult Acute Myeloid Leukemia
Eligibility:
All Genders
60-90 years
Brief Summary
Background: In combination with hypomethylating drugs, venetoclax has recently changed the therapeutic management of patients with newly diagnosed acute myeloid leukemia (AML) for whom standard induct...
Eligibility Criteria
Inclusion
- Subject must have a confirmed diagnosis of previously untreated AML (ELN 2022 criteria) within 28 days of the onset of symptoms. Only previous cytoreductive treatments (e.g. hydroxyurea) are authorized.
- Subject must be ineligible for standard cytarabine and anthracycline induction therapy according to the following criteria:
- Subject aged ≥ 75 years.
- OR subject aged between 60 and 74 with at least one of the following comorbidities:
- ECOG performance status: of 2 or 3.
- cardiac history: heart failure requiring treatment, left ventricular ejection fraction ≤ 50%, chronic stable angina.
- carbon monoxide diffusion capacity ≤ 65% or forced expiratory volume in one second ≤ 65%.
- creatinine clearance between 30 and 45 mL/min/m².
- liver damage (not related to AML) with total bilirubin between 1.5 and 3 × upper normal limit.
- any other comorbidity deemed by the physician to be incompatible with standard induction chemotherapy.
- Patients are eligible for the recommended standard treatment, i.e. a combination of venetoclax and a hypomethylating agent.
- Subjects must voluntarily sign and date an informed consent form authorized by the relevant authorities.
- The participation of the subject in another interventional study not interfering with the pathophysiological, pharmacological and clinical rationale of this protocol is possible.
Exclusion
- blood leukocytes \>25 G/L.
- Subject has already received anticancer treatment (drugs, surgery, radiotherapy) for AML, hematological malignancy or malignant cancer (within the last 2 years).
- Subjects with AML with central nervous system involvement or promyelocytic type (AML-M3).
- Subject to an uncontrolled intercurrent disease such as:
- infection (viral, bacterial or fungal) requiring treatment;
- symptomatic congestive heart failure;
- unstable angina pectoris
- cardiac arrhythmia
- psychiatric illness or drug addiction that would limit compliance with study requirements (risk of treatment non-adherence or low venous capital).
- Documented hypersensitivity to the drugs used to treat the subject.
- Subject has been exposed to potent CYP450 inducers or inhibitors (including grapefruit, Seville oranges) within 7 days prior to treatment initiation.
Key Trial Info
Start Date :
April 8 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06045819
Start Date
April 8 2024
End Date
January 1 2026
Last Update
February 28 2025
Active Locations (1)
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1
CHU de Caen
Caen, France, 14000