Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

Excluded: FLT3 internal tandem duplication

AML without demonstrated FLT3/internal tandem duplication (ITD) mutation

Allowed: CD33 negative leukemic blasts

participants with CD33 negative leukemic blasts (determined at local lab) are eligible for the study but will not be treated with gemtuzumab ozogamicin

Cannot have received: cytotoxic chemotherapy

Exception: corticosteroids, low dose cytarabine or hydroxyurea allowed up to 24 hours prior

Must not have received cytotoxic chemotherapy within 14 days prior to start of protocol treatment, except for corticosteroids, low dose cytarabine or hydroxyurea that can be given up to 24 hours prior

Cannot have received: antibody-drug conjugate

≥ 21 days must have elapsed from infusion of last dose of an antibody-drug conjugate before start of protocol treatment

Cannot have received: unmodified antibody or T cell engaging antibody

For unmodified antibodies or T cell engaging antibodies, 2 half-lives must have elapsed before start of protocol treatment

Cannot have received: interleukins, interferons, cytokines (other than hematopoietic growth factors)

≥ 21 days after the completion of interleukins, interferon or cytokines (other than Hematopoietic Growth Factors) before start of protocol treatment

Cannot have received: hematopoietic growth factor (pegfilgrastim)

≥ 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or ≥7 days for short-acting growth factor before start of protocol treatment

Cannot have received: radiation therapy

≥ 14 days have elapsed for local palliative RT (small port); ≥ 84 days must have elapsed if prior craniospinal RT or if ≥ 50% radiation of pelvis; ≥ 42 days must have elapsed if other substantial bone marrow (BM) radiation

Cannot have received: allogeneic bone marrow or stem cell transplant

≥ 84 days since allogeneic (non-autologous) bone marrow or stem cell transplant (with or without total body irradiation [TBI]) or boost infusion (any stem cell product; not including donor lymphocyte infusion [DLI])

Cannot have received: donor lymphocyte infusion or any type of cellular therapy

≥ 42 days after the completion of donor lymphocyte infusion (DLI) or any type of cellular therapy (e.g., modified T cells, natural killer [NK] cells, dendritic cells, etc.) before start of protocol treatment