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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04726241




Registration number
NCT04726241
Ethics application status
Date submitted
22/01/2021
Date registered
27/01/2021
Date last updated
22/04/2024

Titles & IDs
Public title
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
Scientific title
Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias
Secondary ID [1] 0 0
NCI-2021-00056
Secondary ID [2] 0 0
APAL2020SC
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukemia 0 0
Acute Myeloid Leukemia 0 0
Acute Myeloid Leukemia Post Cytotoxic Therapy 0 0
Juvenile Myelomonocytic Leukemia 0 0
Mixed Phenotype Acute Leukemia 0 0
Myelodysplastic Syndrome 0 0
Myelodysplastic Syndrome Post Cytotoxic Therapy 0 0
Myeloid Leukemia Associated With Down Syndrome 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Blood 0 0 0 0
Haematological diseases
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Human Genetics and Inherited Disorders 0 0 0 0
Down's syndrome
Blood 0 0 0 0
Other blood disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Biospecimen Collection

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).


Treatment: Surgery: Biospecimen Collection
Undergo collection of blood and/or bone marrow samples
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients with identification of a priori specified genomic and immunophenotypic targets who enroll on a sub-trial
Timepoint [1] 0 0
Up to 5 years

Eligibility
Key inclusion criteria
- Patients must be less than 22 years of age at the time of study enrollment

- Patient must have one of the following:

- Patient has known or suspected relapsed/refractory (including primary refractory)
AML

- This includes isolated myeloid sarcoma

- Patient has 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 (MPAL)

- Patient has known or suspected de novo or relapsed/refractory (including primary
refractory) treatment-related AML (t-AML) or treatment-related myelodysplastic
syndrome (t-MDS)

- Patient has known or suspected de novo or relapsed/refractory (including primary
refractory) myelodysplastic syndrome (MDS)

- Patient has known or suspected de novo or relapsed/refractory (including primary
refractory) juvenile myelomonocytic leukemia (JMML)

- 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
Minimum age
No limit
Maximum age
22 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Screening
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
960
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [3] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [4] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment postcode(s) [4] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
Country [4] 0 0
United States of America
State/province [4] 0 0
Arkansas
Country [5] 0 0
United States of America
State/province [5] 0 0
California
Country [6] 0 0
United States of America
State/province [6] 0 0
Colorado
Country [7] 0 0
United States of America
State/province [7] 0 0
Connecticut
Country [8] 0 0
United States of America
State/province [8] 0 0
Delaware
Country [9] 0 0
United States of America
State/province [9] 0 0
District of Columbia
Country [10] 0 0
United States of America
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Florida
Country [11] 0 0
United States of America
State/province [11] 0 0
Georgia
Country [12] 0 0
United States of America
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Hawaii
Country [13] 0 0
United States of America
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Idaho
Country [14] 0 0
United States of America
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Illinois
Country [15] 0 0
United States of America
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Indiana
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United States of America
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Iowa
Country [17] 0 0
United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maine
Country [20] 0 0
United States of America
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Maryland
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United States of America
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Massachusetts
Country [22] 0 0
United States of America
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Michigan
Country [23] 0 0
United States of America
State/province [23] 0 0
Minnesota
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United States of America
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Mississippi
Country [25] 0 0
United States of America
State/province [25] 0 0
Missouri
Country [26] 0 0
United States of America
State/province [26] 0 0
Nebraska
Country [27] 0 0
United States of America
State/province [27] 0 0
Nevada
Country [28] 0 0
United States of America
State/province [28] 0 0
New Hampshire
Country [29] 0 0
United States of America
State/province [29] 0 0
New Jersey
Country [30] 0 0
United States of America
State/province [30] 0 0
New York
Country [31] 0 0
United States of America
State/province [31] 0 0
North Carolina
Country [32] 0 0
United States of America
State/province [32] 0 0
North Dakota
Country [33] 0 0
United States of America
State/province [33] 0 0
Ohio
Country [34] 0 0
United States of America
State/province [34] 0 0
Oklahoma
Country [35] 0 0
United States of America
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Oregon
Country [36] 0 0
United States of America
State/province [36] 0 0
Pennsylvania
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United States of America
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Rhode Island
Country [38] 0 0
United States of America
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South Carolina
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United States of America
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South Dakota
Country [40] 0 0
United States of America
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Tennessee
Country [41] 0 0
United States of America
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Texas
Country [42] 0 0
United States of America
State/province [42] 0 0
Utah
Country [43] 0 0
United States of America
State/province [43] 0 0
Virginia
Country [44] 0 0
United States of America
State/province [44] 0 0
Washington
Country [45] 0 0
United States of America
State/province [45] 0 0
West Virginia
Country [46] 0 0
United States of America
State/province [46] 0 0
Wisconsin
Country [47] 0 0
Canada
State/province [47] 0 0
Alberta
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Canada
State/province [48] 0 0
British Columbia
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Canada
State/province [49] 0 0
Manitoba
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Canada
State/province [50] 0 0
Nova Scotia
Country [51] 0 0
Canada
State/province [51] 0 0
Ontario
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Canada
State/province [52] 0 0
Quebec
Country [53] 0 0
New Zealand
State/province [53] 0 0
Auckland
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New Zealand
State/province [54] 0 0
Christchurch
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Puerto Rico
State/province [55] 0 0
Caguas

Funding & Sponsors
Primary sponsor type
Other
Name
LLS PedAL Initiative, LLC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Children's Oncology Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Cancer Institute (NCI)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04726241
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michele S Redell
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04726241