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APAL2020SC, Pediatric Acute Leukemia (PedAL) Screening Trial Developing New Therapies for Relapsed Leukemias


Primary Investigator
Walling, Emily
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT04726241
UM Number
2022.020
Age Group
Both
Management Group
CTSU - Oncology
Oncology Group
Childhood Cancers
ID (Protocol)
39287
Secondary Protocol No
HUM00210198
Scope
Unspecified
Sponsor Type
Institutional

Disease Site
Leukemia, other
Lymphoid Leukemia
Myeloid and Monocytic Leukemia

Summary
This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults.

Eligibility: Inclusion Criteria
  •   Patients must be less than 22 years of age at the time of study enrollment
  •   Patient must have one of the following:
  •   Patient has known or suspected relapsed/refractory (including primary refractory) AML
  •   This includes isolated myeloid sarcoma
  •   Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome
  •   Patient has known or suspected relapsed ALL 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
  •   Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment related AML
  •   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