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Eganelisib for Relapsed/Refractory AML or High-Risk MDS

This study is testing a drug called eganelisib, both by itself and in combination with cytarabine, for adults with acute myeloid leukemia (AML) or higher-risk myelodysplastic syndromes (MDS) that have come back or are not responding to treatment. The main goals are to see how safe eganelisib is and if it causes any side effects over 12 months. Researchers will also look at how well the treatment works after 12 months. You might be able to join if you are 18 or older and have been diagnosed with AML or higher-risk MDS. The study plans to enroll 125 participants.

Study design
This is a Phase 1b, open-label study, meaning you and your doctors will know which treatment you are receiving. It involves a dose-escalation and dose-optimization approach across multiple centers, with 125 planned participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure side effects and how well the treatment works for 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06533761

Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML

Recruiting
PHASE1Ages 18+InterventionalTreatment
Stelexis BioSciences
~125 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:EganelisibEganelisib in combination with cytarabine

At a glance

Recruiting sites
12 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0
Measured over 12 months
+2 more outcomes measured

Conditions

AML, Adult
MDS

Explore related trials

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Where it's being run

13 sites across 9 states
New York3
Ohio2
Spain2
California1
Colorado1
Florida1
Massachusetts1
Missouri1

Who to contact

Clinical Trials Office Stelexis
[email protected]
508-543-6979
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.012 months
  • Incidence and severity of dose-limiting toxicities (DLTs) in DLT evaluable patients during Cycle 128-35 days
  • Preliminary clinical activity as evaluated per European LeukemiaNet (ELN) 2022 criteria for AML and International Working Group (IWG) 2023 criteria for HR-MDS12 months