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Venetoclax TDM in Newly Diagnosed AML: Exposure-Response and Prognosis

Recruitingn/aAges 16 Years - anyAllThe First Affiliated Hospital of Soochow Universi…
NCT07670130 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Venetoclax combined with azacitidine (VEN-AZA) is the current first-line standard of care for newly diagnosed acute myeloid leukemia (AML) patients unfit for intensive chemotherapy. Although this regimen substantially improves remission rates, marked inter-individual variability is observed in clinical practice-ranging from severe myelosuppression or tumor lysis syndrome in some patients to poor response or early relapse in others. Venetoclax is primarily metabolized by CYP3A4, and its systemic exposure is modulated by multiple factors, including hepatic and renal function, concomitant medications (particularly azole antifungals), and UGT1A1 polymorphisms, leading to a 50%-70% inter-individual variability in blood drug concentrations. Despite this variability, the current VEN-AZA regimen employs a fixed-dose strategy (400 mg/day) without incorporating therapeutic drug monitoring (TDM) t

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Diagnosis: Newly diagnosed acute myeloid leukemia (AML) confirmed according to the WHO 2022 or International Consensus Classification (ICC) criteria, based on bone marrow morphology, flow cytometry, and molecular genetics. Acute promyelocytic leukemia (APL) is excluded. 2. Treatment regimen: Planned or already initiated first-line therapy with venetoclax plus azacitidine (VEN-AZA), with dosing determined by the treating physician according to routine clinical practice (no protocol-mandated dose restrictions). 3. Age: ≥ 16 years. 4. Informed consent: Willingness and ability to provide written informed consent for participation in this observational study. 5. Follow-up: Agreement to attend scheduled follow-up visits and to permit clinical data collection at the time points specified in the study protocol. Exclusion Criteria: 1. Prior AML therapy: Prior treatment for AML, with the exception of leukapheresis, hydroxyurea, low-dose cytarabine, or corticosteroids. 2. Concurrent interventional trials: Current participation in any interventional clinical trial, including those involving investigational agents. 3. Extremely short life expectancy: Judged by the investigator to be unable to complete at least one full cycle of therapy and the associated follow-up.
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What it tests

  • Not listed
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Where

1 site
The first Affiliated Hospital of Soochow University
Suzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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