Venetoclax blood levels and treatment toxicity during hypomethylating-agent combinations for AML in remission
Correlation of Venetoclax Plasma Concentrations With Toxicity of Hypometilating Agents and Venetoclax Combination for Acute Myeloid Leukemia Patients in Remission.
This study will see if venetoclax blood levels are linked to side effects in people with AML who are in remission and receiving hypomethylating agents plus venetoclax.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 14 (estimated) |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Trial ID | NCT07254312 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with newly diagnosed AML who are in remission and receiving HMA plus venetoclax from the first post-remission cycle and who are not taking moderate or strong CYP3A4 inhibitors or inducers and are willing to have plasma level testing.
Not a fit: Patients on moderate or strong CYP3A4 inhibitors/inducers, those not receiving HMA-venetoclax, or those not in remission are unlikely to benefit from the findings of this protocol.
Why it matters
Potential benefit: If a clear link is found, clinicians could use venetoclax blood levels to personalize dosing and reduce hematologic toxicity and treatment interruptions.
How similar studies have performed: While HMA plus venetoclax has proven clinical benefit in AML, using venetoclax plasma concentrations to predict toxicity is relatively novel and not yet established by prior trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Pavia, Pavia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.