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New hope for AML patients: gentler drug combo could replace harsh chemo

NCT ID NCT07664839

Disease control Sponsor: Shen yang 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares a new drug combination (venetoclax plus azacitidine) against standard chemotherapy for adults with a specific type of acute myeloid leukemia (AML) that has NPM1 or IDH mutations. About 148 people will be randomly assigned to one of the two treatments. The main goal is to see if the new combo works as well as standard chemo at achieving remission, while also tracking side effects and long-term 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 combined with azacitidine
What this could lead to
If it works, this could offer a less intensive treatment option for certain AML patients, potentially with fewer side effects than standard chemotherapy.
What could go wrong
This is a phase 2 trial with only 148 participants, so results are preliminary. The new regimen may not be as effective as standard chemo, and side effects are still being studied.

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 148 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

May 2032

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: * Age ≥ 65 years old ≥ 18 years old; * Diagnosed as acute myeloid leukemia (non APL) (diagnostic criteria refer to the 2022 ELN classification system); * Initial diagnosis accompanied by NPM1 mutations (A, B, D types and rare types are all acceptable) and/or IDH1/IDH2 mutations; * Have not received any other induction therapy before (except hydroxyurea); * Physical fitness status score (ECOG PS) 0-3; * Having sufficient organ function, defined as follows: 1. Liver function: serum total bilirubin ≤ 3 x upper limit of normal range (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3 x ULN, unless considered to be caused by leukemia; 2. Renal function: endogenous creatinine clearance rate ≥ 30ml/min; 3. Heart function: NYHA classification ≤ 2 points; * Participants must have the ability to understand and be willing to participate in this study, and sign an informed consent form. Exclusion Criteria: * Acute promyelocytic leukemia; * Merge extramedullary infiltration such as central nervous system leukemia; * Have a clear history of CMML or MDS, and later progress to AML; Or have a history of malignant tumors; * There is uncontrolled active infection (including bacterial, fungal, or viral infections); * Pregnant or lactating women; * Researchers determine that participants are not suitable to participate in this experiment

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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 leukemia IDH1 mutation IDH2 mutation NPM1 mutation

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

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025, China

More trials for these conditions

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