Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia

Eligibility Criteria

• * Ages 1-39 years
• * Diagnosis of one of the following:
• * Acute myeloid leukemia (AML)
• * Acute undifferentiated leukemia (AUL)
• * Mixed phenotype acute leukemia (MPAL)
• * T-cell acute lymphoblastic leukemia (T ALL)
• * Early thymocyte precursor (ETP) ALL
• * KMT2A-rearranged ALL
• * Disease status
• * Relapsed/Refractory AML, MPAL and AUL
• * Relapsed/Refractory KMT2A-rearranged ALL, T-cell ALL, ETP ALL
• * Karnofsky/ Lanksy performance level score of greater than or equal to 50 percent
• * Prior therapy requirements
• * Fully recovered from acute toxicities of Hematopoietic Stem Cell Transplant (HSCT) or Anthracycline Exposure
• * 14 days must have elapsed since the completion of systemic cytotoxic therapy other than hydroxyurea, decitabine or azacitidine
• * 2 weeks must have elapsed for local palliative radiotherapy (RT); 6 months must have elapsed if prior craniospinal RT or if 50% radiation of pelvis, and at least 6 weeks must have elapsed if other substantial bone marrow radiation
• * Adequate renal, liver, cardiac and central nervous system (CNS) function
• * Diagnosis of one of the following:
• * Acute Promyelocytic Leukemia (APML)
• * Acute leukemia with CNS status 3 involvement
• * Philadelphia chromosome positive leukemia (Ph+ ALL, MPAL, or AUL)
• * Fanconi Anemia, Shwachman-Diamond syndrome, or any other bone marrow failure syndrome or DNA repair disorder
• * Wilson's Disease or other copper-metabolism disorder
• * Pregnant or breastfeeding
• * Uncontrolled infection
• * Received greater than 13.6 Gray (Gy) prior radiation to the mediastinum
• * Unable to swallow tablets
• * Receipt of growth factors within 7 days prior to enrollment
• * Currently receiving another investigational drug
• * Currently receiving anti-cancer agents (with the exception of intrathecal (IT) agents or hydroxyurea)
• * Unable to comply with the safety monitoring requirements of the study