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New drug cocktail aims to beat back tough leukemia

NCT ID NCT06084819

Disease control Sponsor: Chinese PLA General Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests whether adding venetoclax to a five-drug regimen (CACAG) works better than standard treatments for people whose acute myeloid leukemia has returned or not responded. About 200 adults aged 14 to 75 will be randomly assigned to one of the two approaches. The main goal is to see how many patients achieve remission after one treatment cycle.

What this could mean

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

Active substance
Venetoclax combined with azacytidine, cytarabine, aclacinomycin, chidamide, and granulocyte colony-stimulating factor
What this could lead to
If successful, this could offer a new treatment option for people with relapsed or hard-to-treat acute myeloid leukemia.
What could go wrong
This is a Phase 2 trial with 200 participants, so results are still early. The combination may cause serious side effects and may not work better than existing therapies.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

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

Started

Aug 2023

Expected to finish

Jan 2030

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

14 to 75 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: * Patients who are able to understand and willing to sign the informed consent form (ICF). * All patients should aged 14 to 75 years,no gender limitation. * Patients with R/R AML, diagnosed in accordance with the 2021 edition of the CMA criteria * Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal; * Renal function: creatinine ≤the upper limit of normal; * Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness; * The score of Eastern Cooperative Oncology Group (ECOG) is 0-3,and the predicted survival ≥ 4 months. * Patients without severe allergic constitution. Exclusion Criteria: * Patients with allergy or contraindication to the study drug; * Female patients who are pregnant or breast-feeding. * Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment; * Patients with mental illness or other states unable to comply with the protocol; * Less than 6 weeks after surgical operation of important organs. * Liver function: ALT and AST\>2.5 times the upper limit of normal ,bilirubin\>2 times the upper limit of normal;Renal function: creatinine \>the upper limit of normal; * The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)

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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.

Relapsed/refractory acute myeloid leukemia

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

  • Chinese PLA General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100853, China

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