A Study of BTX-A51 in People With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Exclusion Criteria

• •Diagnosis of acute promyelocytic leukemia
• •White blood cell count \> 20 x 10\^9/L
• •Receipt of cancer chemotherapy (other than hydroxyurea) within 2 weeks prior to the start of study drug
• •In participants who have undergone autologous or allogeneic stem cell transplantation: transplantation within the 3 months prior to Screening; active graft-versus-host disease requiring anything other than topical corticosteroids and budesonide; treatment with systemic immunosuppressive medications including high-dose steroids (≥ 20 mg prednisolone or equivalent per day), or calcineurin inhibitors (e.g., cyclosporine, tacrolimus) for at least 1 week prior to Screening, and sirolimus, mycophenylate mofetil, azathioprine, or ruxolitinib for at least 2 weeks prior to Screening
• •Immediate life-threatening severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation
• •Persistent toxicities from prior treatment of Grade 2 or higher
• •Active uncontrolled systemic fungal, bacterial, mycobacterial, or viral infection
• •Clinically significant cardiac disease
• •Known dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally
• •Any other concurrent medical condition or disease that is likely to interfere with study procedures or results, or that, in the opinion of the Investigator, would constitute a hazard for participating in this study
• •If female, pregnant or breastfeeding