Can measuring drug levels reduce chemo side effects in leukemia patients?
NCT ID NCT07254312
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at how much venetoclax is in the blood of people with acute myeloid leukemia (AML) who are in remission and still receiving treatment. The goal is to see if higher drug levels are linked to more severe side effects, like low white blood cell counts. By understanding this, doctors hope to adjust doses to make treatment safer and more tolerable. The study will enroll 14 participants and measure venetoclax levels using a special lab test.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- venetoclax
- What this could lead to
- If successful, this could help doctors personalize venetoclax dosing to reduce severe side effects while keeping leukemia in remission.
- What could go wrong
- This is a very small, early observational study with only 14 participants. It is not testing a new treatment, so it may not lead to immediate changes in care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 14 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Study population: patients with newly diagnosed Acute Myeloid Leukemia treated with HMA-VEN in disease remission (from the first post-remission cycle). Patients will be excluded if they are undergoing treatment with moderate or strong Cytochrome 3A4 inhibitors or inducers, or if they are unwilling to receive treatment as previously specified and to be tested for VEN plasma levels at the previously specified timepoint.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fondazione IRCCS Policlinico San Matteo, SC Oncologia
RECRUITINGPavia, Pavia, 27100, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new drug combo reset the immune system to beat relapsed leukemia?
- New chemo cocktail aims to boost stem cell transplant success in leukemia
- New blood test may predict cancer relapse after transplant
- Fitness check may guide better leukemia care for seniors
- New trial aims to match AML patients with best drug combo