Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a fourth drug tip the scales against an aggressive leukemia?

NCT ID NCT07726576

Cure Sponsor: University Hospital, Bordeaux 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This trial is testing whether adding venetoclax to standard intensive chemotherapy plus midostaurin can improve outcomes for adults with a type of acute myeloid leukemia that has a FLT3 mutation. The study enrolls people aged 18 to 70 with newly diagnosed disease who are healthy enough for strong chemotherapy. Researchers are looking for higher rates of complete remission without detectable cancer cells, and longer survival.

What this could mean

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

Active substance
venetoclax added to standard chemotherapy (daunorubicin and cytarabine) plus midostaurin
What this could lead to
If successful, this four-drug combination could become a new standard treatment that improves remission and survival for people with this aggressive leukemia.
What could go wrong
This is an early-phase trial with only 41 participants, so the added benefit and safety of venetoclax in this intensive regimen are not yet known. Adding more drugs may increase side effects.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 41 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

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 70 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.

Main inclusion criteria: 1. Age ≥18 years and ≤70 years 2. Newly diagnosed AML according to World Health Organization (WHO) 2022 classification 3. Documented FLT3 gene mutation (-TKD D835 or I836 or -ITD or both) FLT3-ITD is assessed by DNA fragment analysis. Positivity is defined as an ITD/wt ratio of ≥ 0.05 (5%). FLT3-TKD D835 or I836 is assessed by NGS. Positivity is defined as a VAF \> 5%. 4. Patient must be eligible for intensive chemotherapy. Main exclusion criteria: 1. Prior treatment for AML or myelodysplastic (MDS) phase. 2. Prior exposure to VEN or other BCL2 inhibitors 3. AML secondary to prior hematological disorders, including myelodysplastic syndrome, myeloproliferative disorders and/or therapy-related AML. 4. Acute promyelocytic leukemia, CBF-AML, Phi+ AML 5. Significant active cardiac disease within 6 months prior to the start of study treatment or QTc interval using Fridericia's formula (QTcF) ≥ 450 msec. 6. Cardiac ejection fraction \<45%

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Leukemia, myeloid, acute are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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.

Leukemia, myeloid, acute

How to take part

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

  1. The places running it

    3 sites. 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

  • CH de la Côte Basque

    Bayonne, 64100, France

  • CHU de Bordeaux - Hôpital haut-Lévêque

    Pessac, 33600, France

  • CHU de Toulouse

    Toulouse, 31059, France

More trials for these conditions

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