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New drug cocktail aims to wipe out lingering leukemia

NCT ID NCT07264010

Disease control Sponsor: Nanfang Hospital, Southern Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether combining two oral drugs, sorafenib and venetoclax, can eliminate leftover leukemia cells in people with acute myeloid leukemia (AML) who still have measurable residual disease (MRD) after initial treatment. About 87 participants will receive the drugs for 28-day cycles. The main goal is to see if the treatment reduces MRD levels by at least 90% after three cycles.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sorafenib and venetoclax (two drugs taken by mouth)
What this could lead to
If it works, this combination could help eliminate leftover leukemia cells that standard treatment missed, potentially lowering the chance of relapse.
What could go wrong
This is an early-to-mid stage trial with only 87 people and no comparison group, so results may not apply broadly. Both drugs can cause serious side effects like liver problems or low blood counts.

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.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 87 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2028

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.

Ages

18 to 65 years

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: * Voluntary signing of informed consent form; * Liver and kidney function: Blood bilirubin ≤ 35 μ mol/L, AST/ALT \< 2 times the upper limit of normal, blood creatinine ≤ 150 μ mol/L; * Normal heart function (EF ≥ 50%, NYHA I/II); * Physical condition score 0-2 (ECOG score); * Non pregnant and lactating women. For all women of childbearing age, a pregnancy test must be conducted to determine hCG levels in order to exclude pregnancy status; * For all men of childbearing age, contraceptive measures must be taken during sorafenib treatment until 3 months after discontinuation. Exclusion Criteria: * Acute promyelocytic leukemia; * Hematological non-remisssion or recurrence; * Uncontrolled infection or grade 3-4 graft-versus-host disease (GVHD); * Allergies or contraindications to any of the drugs involved in the protocol; * Severe organ dysfunction such as heart, liver, kidneys, lungs, etc.

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Conditions

The condition(s) this trial relates to.

acute myeloblastic leukemia with maturation acute myeloid leukemia Neoplasm, Residual

As listed by the trial registrant

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

Acute myeloid leukaemia (AML) Measurable residual disease (MRD)

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.