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OncoMatch/Clinical Trials/NCT06533761

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

Is NCT06533761 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Eganelisib and Eganelisib in combination with cytarabine for aml, adult.

Phase 1RecruitingStelexis BioSciencesNCT06533761Data as of May 2026

Treatment: Eganelisib · Eganelisib in combination with cytarabine — This is a Phase 1b open-label, multicenter, dose-escalation and dose-optimization study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy of eganelisib as monotherapy and in combination with cytarabine in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) or r/r higher-risk myelodysplastic syndromes (HR-MDS). The study consists of 2 parts: * Part 1: Dose Escalation (DE) in both monotherapy and in combination. * Part 2: Dose Optimization

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: stem cell transplant

Exception: allowed if >6 months prior to Cycle 1 Day 1

Autologous or allogeneic stem cell transplant within 6 months prior to Cycle 1 Day 1

Lab requirements

Kidney function

Adequate renal function measured within 7 days prior to the first dose of eganelisib

Liver function

Adequate hepatic function measured within 7 days prior to the first dose of eganelisib

Adequate hepatic and renal function measured within 7 days prior to the first dose of eganelisib

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope · Duarte, California
  • Anshutz Cancer Pavilion · Aurora, Colorado
  • Moffitt Cancer Center · Tampa, Florida
  • Dana-Farber Cancer Institute · Boston, Massachusetts
  • Washington University in St Louis · St Louis, Missouri

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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