The Pediatric Acute Leukemia (PedAL) Screening Trial - A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat
About
Pediatric Acute Leukemia (PedAL) Screening Trial – Developing New Therapies for Relapsed Leukemias
This clinical trial aims to use clinical and biological characteristics of acute leukemias to screen 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 best to treat it, and it may help doctors find better ways to diagnose and treat leukemias in children, adolescents and young adults.
Study Plan: This study wants to utilize biological and clinical characteristics of acute leukemias to screen for patient eligibility for other clinical trials as well as maintain a longitudinal registry from relapse in children and young adults with recurrent and refractory leukemia.
COG # APAL2020SC
Eligibility Criteria
Inclusion Criteria
- Patient must be less than 22 years of age at time of study enrollment
- Patient must have one of the following:
- Known or suspected relapsed/refractory (including primary refractory) AML
- This includes isolated myeloid sarcoma
- Known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome
- Known or suspected relapsed/refractory (including primary refractory) AML
- 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
- Patient has known or suspected de novo or relapsed/refractory (including primary refractory) myelodysplastic syndrome (MDS)
- Patient has known or suspected de novo or relapsed/refractory (including primary refractory) juvenile myelomonocytic leukemia (JMML)
- All patients/guardians must sign a written informed consent
Exclusion Criteria
- There are no exclusion criteria for this study.
Primary Investigator
Dr. Glenn Edwards is the section chief of Pediatric Hematology/Oncology, as well as the Children's Oncology Group's principal investigator for Carilion Clinic. With over 30 years of clinical experience, he is board certified by the American Board of Pediatrics in Pediatrics and Pediatric Hematology/Oncology. He completed his fellowship at Walter Reed Army Medical Center and completed his internship and residency at Tripler Army Medical Center.
Contact Information
Wendy McCarty, CCRP
Clinical Research Coordinator
Sydnee Moses, BS
Clinical Research Coordinator
