Venetoclax blood levels and treatment toxicity during hypomethylating-agent combinations for AML in remission

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, single-center project will measure venetoclax plasma concentrations in patients with newly diagnosed AML who are in remission and receiving hypomethylating agent (HMA) plus venetoclax from the first post-remission cycle. Blood levels will be correlated with recorded hematologic and non-hematologic toxicities, dose interruptions, and dose adjustments. Patients taking moderate or strong CYP3A4 inhibitors or inducers will be excluded to avoid confounding drug interactions. The aim is to identify whether higher or lower venetoclax exposure predicts clinically important toxicity that leads to treatment changes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* patients with newly diagnosed Acute Myeloid Leukemia treated with HMA-VEN in disease remission (from the first post-remission cycle).

Exclusion Criteria:

* undergoing treatment with moderate or strong Cytochrome 3A4 inhibitors or inducers,
* unwilling to receive treatment as previously specified and to be tested for VEN plasma levels at the previously specified timepoint.

Where it's running

• Fondazione IRCCS Policlinico San Matteo, SC Oncologia
  Pavia, Pavia, Italy Recruiting

Study contacts

• Study coordinator: Patrizia Zappasodi
• Email: p.zappasodi@smatteo.pv.it
• Phone: +390382503070

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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.