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 Children’s Oncology Group Study

Active:	Yes
Cancer Type:	Cancer-Related Syndrome Leukemia Myelodysplastic Syndromes (MDS)	NCT ID:	NCT04726241
Trial Phases:	Phase II	Protocol IDs:	APAL2020SC (primary) APAL2020SC NCI-2021-00056
Eligibility:	0 - 22 Years, Male and Female	Study Type:	Screening
Study Sponsor:	Children's Oncology Group
NCI Full Details:	http://clinicaltrials.gov/show/NCT04726241

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.

Objectives

PRIMARY OBJECTIVES:
I. To utilize clinical and biological characteristics of acute leukemias to screen for patient eligibility for available phase I/II Pediatric Acute Leukemia (PedAL) sub-trials.
II. To maintain a longitudinal and comprehensive registry, as well as a specimen bank, from relapse in children and young adults with acute leukemias.

OUTLINE:
Patients undergo collection of blood and/or bone marrow samples at baseline, end of treatment cycle(s), and at relapse/refractory disease status (if applicable).

After completion of study, patients are followed up every 3 months for 2 years, and then every 6 months for 3 years.

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