A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and Relapsed /Refractory Pediatric Acute Leukemia Patients

Exclusion Criteria

• •1. Patients with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment.
• •2. The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of hydroxyurea for patients with rapidly proliferative disease or for control of counts during differentiation syndrome. (3) use of steroids for treatment of differentiation syndrome.
• •3. Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.
• •4. Patients with a concurrent active malignancy under treatment.
• •5. Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection.
• •6. Female subjects who are pregnant or breast-feeding.
• •7. Patient has an active uncontrolled infection.
• •8. Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class .II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.
• •9. QTc \>450 msec for males and QTc \>470 msec for females using the Fridericia Formula.
• •10. History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the patient fs participation for the full duration of the study, or is not in the best interest of the patient to participate.
• •11. Clinically active central nervous system (CNS) leukemia.
• •12. Patients on immunosuppressive therapy post-HSCT at the time of screening with R/R leukemia (must be off all systemic immunosuppression therapy for at least 2 weeks and calcineurin inhibitors for at least 4 weeks). The use of topical steroids for cutaneous graft-versus-host disease (GVHD) or stable systemic steroid doses less than or equal to 0.2-0.3mg/kg of prednisone daily are permitted.
• •13. Patients GVHD grade \>1 is not allowed.