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Blood test may personalize leukemia drug dosing

NCT ID NCT07670130

Knowledge-focused Sponsor: The First Affiliated Hospital of Soochow University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 4 times

Summary

This study looks at whether measuring the amount of venetoclax in the blood can help doctors give the right dose to people with newly diagnosed acute myeloid leukemia (AML). Currently, everyone gets the same dose, but drug levels vary a lot between patients. The goal is to find a blood concentration range that works best—boosting remission while limiting side effects like low blood counts. Fifty patients will be followed to see how drug levels relate to outcomes.

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 lead to personalized dosing of venetoclax for AML patients, potentially improving remission rates and reducing severe side effects.
What could go wrong
This is a small, early-phase study with only 50 participants, so results may not apply to all patients. The approach may not clearly improve outcomes over standard fixed dosing.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

This prospective study included newly diagnosed AML patients who received the venetoclax plus azacitidine as induction. Venetoclax concentration data were collected on days 8, 15, and 22, and the steady-state trough concentration (Cmin), peak concentration (Cmax), and area under the curve (AUC) were calculated. The relationships between venetoclax exposure levels (Cmax, Cmin, and AUC) and efficacy, safety, survival, and individual patient characteristics were analyzed.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show 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: 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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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukema Acute myeloid leukemia (AML)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The first Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, 21500, China

More trials for these conditions

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