Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML/HR-MDS and in Combination With Azacitidine in Previously Untreated HR-MDS
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.
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 or Higher Risk Myelodysplastic Syndrome and Eganelisib in Combination With Azacitidine in PI3K-Gamma-Positive Patients With Previously Untreated Higher Risk Myelodysplastic Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 1b open-label, multicenter, dose-escalation and randomized combination cohort 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) and in combination with azacitidine in PI3K-Gamma-Positive patients with previously untreated HR-MDS. The study consists of 2 parts: * Part 1: Dose Escalation (DE) in both monotherapy and in combination with cytarabine. * Part 2: Randomized Combination Cohort: eganelisib + azacitidine and azacitidine alone
Study identification
- NCT ID
- NCT06533761
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 105 participants
Conditions and interventions
Conditions
Interventions
- Eganelisib Drug
- Eganelisib in combination with cytarabine Drug
- Eganelisib in combination with azacitidine Drug
- Azacitadine (AZA) Drug
Drug
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 28, 2025 (Actual)
- Primary completion
- Dec 15, 2027 (Estimated)
- Completion
- Sep 15, 2028 (Estimated)
- Last update posted
- Oct 20, 2026
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.
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 20, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06533761 live on ClinicalTrials.gov.