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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

Sponsor
LLS PedAL Initiative, LLC (Other)
Overall Status
Recruiting
CT.gov ID
NCT04726241
Collaborator
Children's Oncology Group (Other), National Cancer Institute (NCI) (NIH)
960
Enrollment
66
Locations
50
Anticipated Duration (Months)
14.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Biospecimen Collection

Detailed Description

PRIMARY OBJECTIVES:

  1. 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.

  2. 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

Study Type:
Observational
Anticipated Enrollment :
960 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias
Actual Study Start Date :
Nov 30, 2021
Anticipated Primary Completion Date :
Jan 30, 2026
Anticipated Study Completion Date :
Jan 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Observational (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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients with identification of a priori specified genomic and immunophenotypic targets who enroll on a sub-trial [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

    Criteria

    Ages Eligible for Study:
    N/A to 22 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Alabama Birmingham Alabama United States 35233
    2 USA Health Strada Patient Care Center Mobile Alabama United States 36604
    3 Banner University Medical Center - Tucson Tucson Arizona United States 85719
    4 Arkansas Children's Hospital Little Rock Arkansas United States 72202-3591
    5 Kaiser Permanente-Oakland Oakland California United States 94611
    6 UCSF Medical Center-Mission Bay San Francisco California United States 94158
    7 Alfred I duPont Hospital for Children Wilmington Delaware United States 19803
    8 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
    9 Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida United States 33021
    10 Nemours Children's Hospital Orlando Florida United States 32827
    11 Sacred Heart Hospital Pensacola Florida United States 32504
    12 Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida United States 33607
    13 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
    14 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    15 Lurie Children's Hospital-Chicago Chicago Illinois United States 60611
    16 Saint Jude Midwest Affiliate Peoria Illinois United States 61637
    17 Riley Hospital for Children Indianapolis Indiana United States 46202
    18 University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa United States 52242
    19 Norton Children's Hospital Louisville Kentucky United States 40202
    20 Maine Children's Cancer Program Scarborough Maine United States 04074
    21 Michigan State University Clinical Center East Lansing Michigan United States 48824-7016
    22 Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan United States 49503
    23 University of Minnesota/Masonic Cancer Center Minneapolis Minnesota United States 55455
    24 University of Mississippi Medical Center Jackson Mississippi United States 39216
    25 Children's Mercy Hospitals and Clinics Kansas City Missouri United States 64108
    26 Cardinal Glennon Children's Medical Center Saint Louis Missouri United States 63104
    27 Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada United States 89135
    28 Summerlin Hospital Medical Center Las Vegas Nevada United States 89144
    29 Morristown Medical Center Morristown New Jersey United States 07960
    30 Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick New Jersey United States 08903
    31 Saint Joseph's Regional Medical Center Paterson New Jersey United States 07503
    32 NYU Winthrop Hospital Mineola New York United States 11501
    33 The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York United States 11040
    34 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    35 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    36 New York Medical College Valhalla New York United States 10595
    37 Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina United States 28203
    38 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    39 Nationwide Children's Hospital Columbus Ohio United States 43205
    40 Dayton Children's Hospital Dayton Ohio United States 45404
    41 ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio United States 43606
    42 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    43 Geisinger Medical Center Danville Pennsylvania United States 17822
    44 Saint Christopher's Hospital for Children Philadelphia Pennsylvania United States 19134
    45 Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania United States 15224
    46 Medical University of South Carolina Charleston South Carolina United States 29425
    47 Saint Jude Children's Research Hospital Memphis Tennessee United States 38105
    48 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    49 Dell Children's Medical Center of Central Texas Austin Texas United States 78723
    50 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    51 El Paso Children's Hospital El Paso Texas United States 79905
    52 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
    53 Children's Hospital of San Antonio San Antonio Texas United States 78207
    54 Methodist Children's Hospital of South Texas San Antonio Texas United States 78229
    55 Primary Children's Hospital Salt Lake City Utah United States 84113
    56 Inova Fairfax Hospital Falls Church Virginia United States 22042
    57 Children's Hospital of The King's Daughters Norfolk Virginia United States 23507
    58 Mary Bridge Children's Hospital and Health Center Tacoma Washington United States 98405
    59 Madigan Army Medical Center Tacoma Washington United States 98431
    60 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53792
    61 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    62 University of Alberta Hospital Edmonton Alberta Canada T6G 2B7
    63 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
    64 IWK Health Centre Halifax Nova Scotia Canada B3K 6R8
    65 Children's Hospital London Ontario Canada N6A 5W9
    66 Hospital for Sick Children Toronto Ontario Canada M5G 1X8

    Sponsors and Collaborators

    • LLS PedAL Initiative, LLC
    • Children's Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Todd M Cooper, Children's Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Douglas Hawkins, MD, Douglas Hawkins, MD, Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT04726241
    Other Study ID Numbers:
    • APAL2020SC
    • NCI-2021-00056
    • APAL2020SC
    • APAL2020SC
    • U10CA180886
    First Posted:
    Jan 27, 2021
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Jul 1, 2022
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid
    Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
    Recurrence
    Acute Disease

    Study Results

    No Results Posted as of Aug 19, 2022