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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

PHASE1PHASE2RECRUITING

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.

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Study details:

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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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

Eligibility

Age eligible for study : 0 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-04-18

Primary completion: 2026-12-31

Study completion finish: 2026-12-31

Study type

SCREENING

Phase

PHASE1

PHASE2

Trial ID

NCT04726241

Intervention or treatment

PROCEDURE: Biospecimen Collection

Conditions

• Acute Myeloid Leukemia
• Acute Lymphoblastic 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

Condition: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and more
PROCEDURE: Biospecimen Collection
Westmead, New South Wales, Australia and more
Sponsor: LLS PedAL Initiative, LLC

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

The Children's Hospital at Westmead

Research sites nearby

Select from list below to view details:

The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Royal Children's Hospital
Parkville, Victoria, Australia
Perth Children's Hospital
Perth, Western Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Screening (biospecimen collection) 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).	PROCEDURE: Biospecimen Collection Undergo collection of blood and/or bone marrow samples

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Proportion of patients with identification of a priori specified genomic and immunophenotypic targets who enroll on a sub-trial	The proportion will be calculated as the percent of eligible patients who are identified to have an a priori specified genomic or immunophenotypic target and who enroll on at least one of the sub-trials. The corresponding confidence interval will be constructed.	Up to 5 years
Maintain a longitudinal and comprehensive registry, as well as specimen bank of children and young adults with acute leukemias	Not Specified	Up to 5 years

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: 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