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New hope for Hard-to-Treat leukemia? early trial combines three drugs

NCT ID NCT07511062

Disease control Sponsor: Northside Hospital, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase trial is testing a new drug called axatilimab added to two standard chemotherapy drugs (decitabine and venetoclax) for people with acute myeloid leukemia (AML) that has a TP53 mutation or deletion. The study aims to find the safest dose of axatilimab and see how many patients achieve remission without detectable cancer cells. It will enroll 32 adults who have not been treated before or are in their first relapse.

What this could mean

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

Active substance
axatilimab combined with decitabine and venetoclax
What this could lead to
If successful, this could offer a new treatment option for people with a hard-to-treat form of acute myeloid leukemia (AML) that has a TP53 mutation.
What could go wrong
This is a very early (Phase 1) trial with only 32 participants, so the main goal is safety and dosing, not proof of effectiveness. The combination may cause side effects or not work better than existing treatments.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 32 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 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

18 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: * MDS/AML or AML with a TP53 mutation or deletion, defined as: * greater than or equal to 10% AND (one of the following): * presence of a TP53 mutation * presence of a TP53 deletion by FISH * positive TP53 staining on IHC of diagnostic bone marrow * Either untreated or first salvage (primary refractory or first relapse) Exclusion Criteria: * KPS \<60 * active uncontrolled infection * history of HIV or active HBV or HBC infection * currently active second malignancy * calculated CrCl \<40mL/min * AST and/or ALT and/or direct bilirubin \>3x ULN * cardiac ejection fraction \<40% or history of uncontrolled cardiac arrhythmias * history of acute or chronic pancreatitis, history of myositis * known leukemia involvement of CNS * hematopoietic stem cell transplantation within 3 months of treatment start and/or persistent non-hematologic toxicities of Grade 2+ related to the transplant * active acute or chronic GVHD requiring immunosuppressive treatment

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia myelodysplastic syndrome

As listed by the trial registrant

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

Acute myeloid leukemia TP53 gene 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

  • Northside Hospital, Inc.

    Atlanta, Georgia, 30342, United States

More trials for these conditions

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