Venetoclax TDM in newly diagnosed AML: exposure and prognosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows patients with newly diagnosed AML who are treated with venetoclax plus azacitidine in routine clinical practice. It examines how differences in drug exposure relate to safety and outcomes, aiming to see if tailoring dose based on drug levels could improve prognosis. Participants are adults and youths (16+) who have not received prior AML therapy (except certain exceptions) and are undergoing standard VEN-AZA regimens. Data will be collected during planned follow-up visits to explore exposure-response relationships in real-world settings. The study does not mandate a fixed dosing protocol and reflects routine care at the participating center.

Why it matters

Who can join: the full rules

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.

Where it's running

• The first Affiliated Hospital of Soochow University
  Suzhou, China Recruiting

Study contacts

• Study coordinator: Jia Chen
• Email: drchenjia@163.com
• Phone: 86+052167976801

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.