Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML (NCT06533761)
A Phase 1b Open-Label Study to Evaluate the Safety and Tolerability of Eganelisib as Monotherapy and in Combination With Cytarabine in Patients With Relapsed/Refractory Acute Myeloid Leukemia
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: City of Hope — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (13 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
- Memorial Sloan Kettering Cancer Center — New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- Montefiore Medical Center — New York, New York
- Cleveland Clinic — Cleveland, Ohio
- Ohio State University — Columbus, Ohio
- MD Anderson Cancer Center — Houston, Texas
- Hospital San Pedro de Alcántara — Cáceres,
- Hospital Universitari i Politècnic La Fe — Valencia,
📞 Contact the Study Coordinator
Phone: (508) 543-6979
Email: clinicaltrials@stelexis.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.