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New hope for hard-to-treat leukemia? early trial tests eganelisib alone and with chemo.

NCT ID NCT06533761

Disease control Sponsor: Stelexis BioSciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Updated 2 times

Summary

This early-phase study tests a new drug called eganelisib, given alone or with standard chemotherapy (cytarabine), in adults with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) that have returned or not responded to prior treatments. The main goals are to check safety, find the best dose, and see if the drug helps control the disease. About 125 participants will take part across multiple centers.

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 125 people

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

Started

Apr 2025

Expected to finish

Mar 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: * Pathological diagnosis of either: AML according to World Health Organization (WHO) 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts (acute promyelocytic leukemia is excluded but secondary AML and treatment-related AML can be included); Higher-risk (IPSS-R Intermediate, High or Very High Risk at time of study entry) myelodysplastic syndromes (HR-MDS) according to WHO 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2. * Adequate hepatic and renal function measured within 7 days prior to the first dose of eganelisib. Exclusion Criteria: * Autologous or allogeneic stem cell transplant within 6 months prior to Cycle 1 Day 1. * Receiving immunosuppressants (eg, cyclosporin) or systemic steroids (except for steroid use as cortisol replacement therapy in documented adrenal insufficiency). * Active fungal disease or uncontrolled infection of any kind; patients receiving antibiotic, antifungal or antiviral treatment must be afebrile and hemodynamically stable for \>72 hours prior to treatment * WBC count \>25 × 10\^9/L measured within 7 days prior to the first dose of eganelisib (hydroxyurea is permitted to decrease the WBC count). * Presence of a clinically significant non-hematologic toxicity of prior therapy that has not resolved to Grade ≤1 or Baseline, whichever is worst, as determined by NCI CTCAE v 5.0, except alopecia or skin pigmentation. Fatigue and neuropathy must have resolved to Grade ≤2.

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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.

AML, adult MDS

How to take part

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

  1. The places running it

    13 sites in 2 countries. 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

  • Anshutz Cancer Pavilion

    RECRUITING

    Aurora, Colorado, 80045, United States

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Hospital San Pedro de Alcántara

    RECRUITING

    Cáceres, 10003, Spain

  • Hospital Universitari i Politècnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77054, United States

  • Memorial Sloan Kettering Cancer Center

    NOT_YET_RECRUITING

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Montefiore Medical Center

    RECRUITING

    New York, New York, 10466, United States

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Washington University in St Louis

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

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