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New combo therapy shows promise for kids with aggressive leukemia

NCT ID NCT03591510

Disease control Sponsor: Novartis Pharmaceuticals 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 2 times

Summary

This study tests whether adding the drug midostaurin to standard chemotherapy helps children with a certain genetic type of acute myeloid leukemia (FLT3-mutated AML). About 22 children will receive the drug twice daily alongside chemo, then continue midostaurin alone for 12 more cycles. The goal is to see if the combination is safe and helps control the disease, but ongoing treatment may be needed.

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

22 people

The number who actually took part.

Started

Mar 2019

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 months to 17 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: * Documented Diagnosis of previously untreated de novo AML according to WHO 2016 criteria * Presence of a FLT3 mutation status as measured/confirmed by a designated lab with results available prior first dose of Midostaurin * Patients with Lansky or Karnofsky performance status equal or superior to 60 * Patient with the following laboratory value : AST and ALT ≤ 3times ULN * Serum Total bilirubin ≤ 1.5times ULN * Estimated creatinine clearance ≥30ml/min Exclusion Criteria: * Any concurrent malignancy, AML with Philadelphia Chromosome, AML-DS, JMML * Symptomatic leukemic CNS involvement * Isolated extramedullary leukemia, secondary AML and MDS * Acute Promyelocytic Leukemia with the PML RARA rearrangement * Patient who have received prior treatment with a FLT3 inhibitor. However, up to 1 week of FLT3 inhibitor (except midostaurin) exposure prior to study enrollment is permissible. Other protocol-defined inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia acute myeloid leukemia, FLT3 internal tandem duplication

As listed by the trial registrant

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

FLT3-mutated acute myeloid leukemia

Contacts and locations

Locations

  • Novartis Investigative Site

    Prague, 150 06, Czechia

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Pavia, PV, 27100, Italy

  • Novartis Investigative Site

    Roma, RM, 00165, Italy

  • Novartis Investigative Site

    Torino, TO, 10126, Italy

  • Novartis Investigative Site

    Naples, 80122, Italy

  • Novartis Investigative Site

    Osaka, 5340021, Japan

  • Novartis Investigative Site

    Amman, 11941, Jordan

  • Novartis Investigative Site

    Krakow, 30-663, Poland

  • Novartis Investigative Site

    Moscow, 117198, Russia

  • Novartis Investigative Site

    Ljubljana, 1000, Slovenia

  • Novartis Investigative Site

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    Adana, Adana, 1330, Turkey (Türkiye)

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