A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat

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Brief Title

A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment or Is Difficult to Treat

Official Title

Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias

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.
    

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 Type

Observational


Primary Outcome

Identification of a priori specified genomic and immunophenotypic targets to inform sub-trial eligibility


Condition

Recurrent Acute Lymphoblastic Leukemia

Intervention

Biospecimen Collection

Study Arms / Comparison Groups

 Observational (biospecimen collection)
Description:  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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

960

Start Date

August 29, 2021

Completion Date

January 30, 2026

Primary Completion Date

January 30, 2026

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must be less than 22 years of age at the time of study enrollment

          -  Patient has known or suspected relapsed/refractory AML

          -  Patient has known or suspected relapsed ALL that meets the following criteria:

               -  Second or greater medullary relapse of B-ALL

               -  Any first or greater B or T-ALL medullary relapse involving KMT2A rearrangement
                  (KMT2Ar)

               -  Any first or greater relapse of T-ALL

          -  Known or suspected relapsed/refractory mixed phenotype acute leukemia

          -  Known or suspected treatment related AML - de novo or relapsed/refractory

          -  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
      

Gender

All

Ages

N/A - 22 Years

Accepts Healthy Volunteers

No

Contacts

Todd M Cooper, , 



Administrative Informations


NCT ID

NCT04726241

Organization ID

APAL2020SC

Secondary IDs

NCI-2021-00056

Responsible Party

Sponsor

Study Sponsor

Children's Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

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


Verification Date

January 2021