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Recruiting Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT06533761

Public ClinicalTrials.gov record NCT06533761. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 28, 2026, 4:30 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT06533761
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Stelexis BioSciences
Industry
Enrollment
125 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 27, 2025
Primary completion
Jul 14, 2027
Completion
Mar 14, 2028
Last update posted
Oct 21, 2025

2025 – 2028

United States locations

U.S. sites
10
U.S. states
8
U.S. cities
9
Facility City State ZIP Site status
City of Hope Duarte California 91010 Recruiting
Anshutz Cancer Pavilion Aurora Colorado 80045 Recruiting
Moffitt Cancer Center Tampa Florida 33612 Recruiting
Dana-Farber Cancer Institute Boston Massachusetts 02215 Recruiting
Washington University in St Louis St Louis Missouri 63110 Recruiting
Memorial Sloan Kettering Cancer Center New York New York 10065 Recruiting
Montefiore Medical Center New York New York 10466 Recruiting
Cleveland Clinic Cleveland Ohio 44106 Recruiting
Ohio State University Columbus Ohio 43210 Recruiting
MD Anderson Cancer Center Houston Texas 77054 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

Recently updated AML, Adult trials

Other public records listing AML, Adult. Sorted by last update posted; newest first. Not a recommendation.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06533761, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 21, 2025 · Synced Jul 28, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06533761 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →