Acute Myeloid Leukemia (AML) Clinical Trials

• Ages 1 Year to 39 Years

• Diagnosis of one of the following:

‣ Acute myeloid leukemia (AML), any subtype except

• Patients with acute promyelocytic leukemia (APML) are NOT eligible

∙ Patients with ML-DS are NOT eligible

⁃ Myeloid sarcoma

⁃ Acute leukemia of ambiguous lineage (ALAL)

• Acute undifferentiated leukemia (AUL)

∙ T/myeloid mixed phenotype acute leukemia (MPAL)

∙ B/myeloid MPAL

∙ MPAL with KMT2A-rearrangement MPAL with t (9;22) are NOT eligible

⁃ T-cell acute lymphoblastic leukemia (T ALL)

⁃ Early thymocyte precursor (ETP) ALL

⁃ KMT2A-rearranged ALL

• Disease Status

‣ Relapsed/Refractory AML, MPA, and AUL

⁃ Untreated therapy related AML

⁃ Relapsed/Refractory KMT2A-rearranged ALL, T-cell ALL, ETEP 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