Using eganelisib alone and with cytarabine for treating relapsed/refractory AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1b open-label study evaluates the safety and effectiveness of eganelisib, both as a standalone treatment and in combination with cytarabine, for patients with relapsed or refractory acute myeloid leukemia (AML) and higher-risk myelodysplastic syndromes (HR-MDS). The study is divided into two parts: a dose escalation phase to determine the appropriate dosage and a dose optimization phase to refine treatment protocols. It aims to assess pharmacokinetics, pharmacodynamics, and anti-tumor efficacy in a multicenter setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Part 1: 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.
* Part 2: Pathological diagnosis of previously untreated HR-MDS according to WHO 2022 revised criteria, with bone marrow blasts ≥5% and \<20%; Moderate or higher PI3K-Gamma in bone marrow blasts, as determined by an IHC assay; Deemed by the Investigator to require frontline therapy with azacitidine.
* 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.

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• Anshutz Cancer Pavilion
  Aurora, Colorado, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Washington University in St Louis
  St Louis, Missouri, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Office Stelexis
• Email: clinicaltrials@stelexis.com
• Phone: 508-543-6979

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.