We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04726241
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : May 23, 2023
Sponsor:
Collaborators:
Children's Oncology Group
National Cancer Institute (NCI)
Information provided by (Responsible Party):
LLS PedAL Initiative, LLC

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Recurrent Acute Lymphoblastic Leukemia Recurrent Acute Myeloid Leukemia Recurrent B Acute Lymphoblastic Leukemia Recurrent Mixed Phenotype Acute Leukemia Recurrent T Acute Lymphoblastic Leukemia Refractory Acute Myeloid Leukemia Refractory Mixed Phenotype Acute Leukemia Therapy-Related Acute Myeloid Leukemia Procedure: Biospecimen Collection Not Applicable

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 from relapse in children and young adults with recurrent and refractory leukemia.

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 960 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias
Actual Study Start Date : November 30, 2021
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    • 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
    • Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment related AML
  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04726241


Locations
Show Show 157 study locations
Sponsors and Collaborators
LLS PedAL Initiative, LLC
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Todd M Cooper Children's Oncology Group
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: LLS PedAL Initiative, LLC
ClinicalTrials.gov Identifier: NCT04726241    
Other Study ID Numbers: APAL2020SC
NCI-2021-00056 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
APAL2020SC ( Other Identifier: Children's Oncology Group )
APAL2020SC ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: November 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Recurrence
Acute Disease
 Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases