Actively Recruiting
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
Led by Stelexis BioSciences · Updated on 2025-10-22
125
Participants Needed
13
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating eganelisib, both alone and combined with cytarabine, in patients with relapsed or refractory acute myeloid leukemia (AML) or higher-risk myelodysplastic syndromes (HR-MDS). This Phase 1b open-label study aims to assess the safety, tolerability, how the body processes the drugs, and early anti-tumor effects. The study is divided into two parts: dose escalation to find safe doses, and dose optimization for treatment refinement. Participants receive eganelisib either as a single drug or together with cytarabine. The study includes a dose escalation phase where doses are gradually increased and a dose optimization phase to fine-tune the treatment. Treatments are given under close medical supervision, and the study is open-label, so both doctors and patients know the treatments being given. During the trial, participants undergo regular assessments to monitor safety, side effects, and preliminary treatment effects according to established leukemia response criteria. Researchers will track adverse events, dose-limiting toxicities, and pharmacokinetic measures such as drug concentrations in the blood. Follow-up includes about one year of safety and activity monitoring. The total participation time varies depending on individual treatment and response.
CONDITIONS
Brief Title
Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory acute myeloid leukemia with 10% or more bone marrow blasts, excluding acute promyelocytic leukemia
- Diagnosis of higher-risk myelodysplastic syndromes with 10% or more bone marrow blasts
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Adequate liver and kidney function measured within 7 days before starting treatment
You will not qualify if you...
- Stem cell transplant received within 6 months prior to starting treatment
- Use of immunosuppressants or systemic steroids except for adrenal insufficiency replacement therapy
- Active fungal disease or uncontrolled infection
- White blood cell count above 25 x 10^9/L within 7 days prior to treatment (hydroxyurea allowed to reduce count)
- Unresolved non-blood related toxicity from previous treatment above Grade 1 or baseline, except hair loss or skin pigmentation
- Fatigue and neuropathy must have improved to Grade 2 or better
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28- to 35-day cycles until disease progression or discontinuation
Participants receive eganelisib either as monotherapy or in combination with cytarabine to evaluate safety and tolerability.
Weekly visits for up to 12 weeks
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
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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