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New pill takes on deadly leukemia in major trial

NCT ID NCT05586074

Disease control Sponsor: Sunshine Lake Pharma Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called HEC73543 (Clifutinib) against standard chemotherapy in 324 adults with a specific type of acute myeloid leukemia (FLT3-ITD) that has come back or not responded to first treatment. The goal is to see if the new drug helps people live longer and achieve remission. Participants are randomly assigned to receive either the new drug or chemotherapy.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 324 people

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

Started

Mar 2023

Expected to finish

May 2028

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

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: * Subject is ≥ 18 years of age at the time of obtaining informed consent. * Subject has a diagnosis of primary acute myeloid leukemia (AML) or AML secondary to myelodysplastic syndrome (MDS) according to WHO classification; * Subject is refractory to or relapsed after first-line AML therapy (with or without hematopoietic stem cell transplant ) * Subject is positive for FLT3 mutation in bone marrow or whole blood as determined by the central lab * Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Subject is eligible for pre-selected salvage chemotherapy at the investigator's discretion Exclusion Criteria: * Subject has received prior treatment with other FLT3 inhibitors * Subject has AML that has relapsed after or is refractory to more than 1 line of therapy * Subject has an active uncontrolled infection * Subject is known to have human immunodeficiency virus infection * Subject has any condition which, in the investigator's opinion, makes the subject unsuitable for study participation

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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.

Leukemia acute myeloid - AML

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

  • the First Affiliated Hospital,College of Medicine,Zhejiang University

    RECRUITING

    Hanzhou, China

More trials for these conditions

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