A screening trial where children and young adults with relapsed or refractory acute leukaemias will have tests to determine what treatment or other trial they may be eligible forPediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias

Inclusion

• Patients must be less than 22 years of age at the time of study enrollment

• Patient must have one of the following at the time of study enrollment:

  • Patient has known or suspected relapsed/refractory (including primary refractory) AML as defined in protocol

    • This includes isolated myeloid sarcoma
  • Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome (ML-DS)

  • Patient has known or suspected relapsed ALL as defined in protocol that meets one of the following criteria:

    • Second or greater B-ALL medullary relapse, excluding KMT2Ar
    • Any first or greater B-ALL medullary relapse involving KMT2Ar
    • Any first or greater T-ALL medullary relapse with or without KMT2Ar
  • Patient has known or suspected relapsed/refractory (including primary refractory) mixed phenotype acute leukemia (MPAL) as defined in protocol
  • Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment-related AML (t-AML)

  • Patient has known or suspected de novo or relapsed/refractory (including primary refractory) myelodysplastic syndrome (MDS) or treatment-related myelodysplastic syndrome (t-MDS)

    • Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse.

  • Patient has known or suspected de novo or relapsed/refractory (including primary refractory) juvenile myelomonocytic leukemia (JMML)

    • Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse.
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met