Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML
NCT ID: NCT06533761
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
125 participants
INTERVENTIONAL
2025-04-28
2028-03-15
Brief Summary
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The study consists of 2 parts:
* Part 1: Dose Escalation (DE) in both monotherapy and in combination.
* Part 2: Dose Optimization
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Eganelisib
Eganelisib
eganelisib will be administered as monotherapy
Eganelisib in combination with cytarabine
Eganelisib in combination with cytarabine
eganelisib will be administered in combination with cytarabine
Interventions
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Eganelisib
eganelisib will be administered as monotherapy
Eganelisib in combination with cytarabine
eganelisib will be administered in combination with cytarabine
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
* Adequate hepatic and renal function measured within 7 days prior to the first dose of eganelisib.
Exclusion Criteria
* Receiving immunosuppressants (eg, cyclosporin) or systemic steroids (except for steroid use as cortisol replacement therapy in documented adrenal insufficiency).
* Active fungal disease or uncontrolled infection of any kind; patients receiving antibiotic, antifungal or antiviral treatment must be afebrile and hemodynamically stable for \>72 hours prior to treatment
* WBC count \>25 × 10\^9/L measured within 7 days prior to the first dose of eganelisib (hydroxyurea is permitted to decrease the WBC count).
* Presence of a clinically significant non-hematologic toxicity of prior therapy that has not resolved to Grade ≤1 or Baseline, whichever is worst, as determined by NCI CTCAE v 5.0, except alopecia or skin pigmentation. Fatigue and neuropathy must have resolved to Grade ≤2.
18 Years
ALL
No
Sponsors
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Stelexis BioSciences
INDUSTRY
Responsible Party
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Locations
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City of Hope
Duarte, California, United States
Anshutz Cancer Pavilion
Aurora, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Washington University in St Louis
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Montefiore Medical Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
Hospital San Pedro de Alcántara
Cáceres, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STLX-EGA-001
Identifier Type: -
Identifier Source: org_study_id
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