Actively Recruiting
Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML
Led by Stelexis BioSciences · Updated on 2025-10-22
125
Participants Needed
13
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathological diagnosis of AML with 10% bone marrow blasts or higher-risk myelodysplastic syndromes with 10% bone marrow blasts
- ECOG performance status 2
- Adequate liver and kidney function within 7 days before first dose of eganelisib
You will not qualify if you...
- Stem cell transplant within 6 months before treatment start
- Use of immunosuppressants or systemic steroids (except cortisol replacement therapy)
- Active fungal infection or uncontrolled infection; must be afebrile and stable for more than 72 hours if on antibiotics, antifungals, or antivirals
- White blood cell count greater than 25 10^9/L within 7 days before first dose (hydroxyurea allowed to lower counts)
- Ongoing serious non-blood toxicity from previous treatments not improved to Grade 1 or baseline (except hair loss or skin color changes); fatigue and neuropathy must be improved to Grade 2 or better
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Anshutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Washington University in St Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Not Yet Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
8
Montefiore Medical Center
New York, New York, United States, 10466
Actively Recruiting
9
Cleveland Clinic
Cleveland, Ohio, United States, 44106
Actively Recruiting
10
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
11
MD Anderson Cancer Center
Houston, Texas, United States, 77054
Actively Recruiting
12
Hospital San Pedro de Alcántara
Cáceres, Spain, 10003
Actively Recruiting
13
Hospital Universitari i Politècnic La Fe
Valencia, Spain, 46026
Actively Recruiting
Research Team
C
Clinical Trials Office Stelexis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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