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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia Post Cytotoxic Therapy, Juvenile Myelomonocytic Leukemia. Basic parameters: up to 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, New Zealand, Puerto Rico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias
Overview
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.
Interventions
- Procedure Biospecimen Collection
Undergo collection of blood and/or bone marrow samples
Primary outcome measures
- Proportion of patients with identification of a priori specified genomic and immunophenotypic targets who enroll on a sub-trial [Time frame: Up to 5 years]
- Maintain a longitudinal and comprehensive registry, as well as specimen bank of children and young adults with acute leukemias [Time frame: Up to 5 years]
Eligibility criteria
Inclusion criteria
- Patients must be less than 22 years of age at the time of study enrollment
- Patient must have one of the following at the time of study enrollment:
- Patient has known or suspected relapsed/refractory (including primary refractory) AML as defined in protocol
- This includes isolated myeloid sarcoma
- Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome (ML-DS)
- Patient has known or suspected relapsed ALL as defined in protocol 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 (MPAL) as defined in protocol
- Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment-related AML (t-AML)
- Patient has known or suspected de novo or relapsed/refractory (including primary refractory) myelodysplastic syndrome (MDS) or treatment-related myelodysplastic syndrome (t-MDS)
- Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse.
- Patient has known or suspected de novo or relapsed/refractory (including primary refractory) juvenile myelomonocytic leukemia (JMML)
- Note: Relapsed/refractory disease includes stable disease, progressive disease, and disease relapse.
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 164 centers
- Children's Hospital of Alabama — Birmingham
- USA Health Strada Patient Care Center — Mobile
- Providence Alaska Medical Center — Anchorage
- Banner Children's at Desert — Mesa
- Phoenix Childrens Hospital — Phoenix
- Banner University Medical Center - Tucson — Tucson
- Arkansas Children's Hospital — Little Rock
- Kaiser Permanente Downey Medical Center — Downey
- … and 156 more centers
Canada · 12 centers
Center list to be confirmed — check the primary protocol.
Australia · 4 centers
Center list to be confirmed — check the primary protocol.
New Zealand · 2 centers
Center list to be confirmed — check the primary protocol.
Puerto Rico · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04726241 · APAL2020SC · NCI-2021-00056 · APAL2020SC · APAL2020SC · U10CA180886