Pediatric Acute Leukemia Screening Trial: Developing New Therapies for Relapsed Leukemias
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; a Leukemia & Lymphoma Society and C...
About
Protocol Description
This Pediatric Acute Leukemia (PedAL) Screening Protocol is sponsored by the Leukemia & Lymphoma Society (LLS) and implemented through the Children’s Oncology Group. This screening protocol will provide a single portal of entry with the long-term collection of clinical, immunophenotype and molecular data for all participants with relapsed or refractory leukemia. This screening trial will improve new agent availability for children, as well as provide an efficient pathway for our pharma partners to fulfill regulatory requirements and drug approval.
COG# APAL2020SC
Eligibility Criteria
Inclusion Criteria
Patient must have one of the following:
- Known or suspected relapsed/refractory (including primary refractory) AML, including isolated myeloid sarcoma
- 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.
Exclusion Criteria
There are no exclusion criteria for this study.
See Protocol Section 3 for a complete comprehensive list of inclusion and exclusion criteria.
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. He has over 30 years of clinical experience and is 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, C.C.R.P.
Clinical Research Coordinator II