NCT04726241

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 960 (estimated)
• Sponsor: PedAL BCU, LLC · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Acute Myeloid Leukemia Post Cytotoxic Therapy
• Juvenile Myelomonocytic Leukemia
• Mixed Phenotype Acute Leukemia
• Myelodysplastic Syndrome
• Myelodysplastic Syndrome Post Cytotoxic Therapy
• Myeloid Leukemia Associated With Down Syndrome

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of blood and/or bone marrow samples

Timeline

• Start date: 2022-04-18
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2021-01-27
• Last updated: 2026-04-08

Locations

182 sites across 5 countries: United States, Australia, Canada, New Zealand, Puerto Rico