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(352) 733-0111

A Study to Test Bone Marrow and Blood in Children With Leukemia That Has Come Back After Treatment o

  • Status
    Accepting Candidates
  • Age
    N/A - 22 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

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, 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.

Details

Full study title Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias
Protocol number OCR41935
ClinicalTrials.gov ID NCT04726241
Phase Phase 1/Phase 2

Eligibility

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

Lead researchers

  • William Slayton, MD
    Pediatric Hematologist/Oncologist (Child Cancer Specialist)
    William Slayton
  • Brian Stover, MD
    Pediatric Hematologist/Oncologist (Child Cancer Specialist)
    Brian Stover

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

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  4. Step
    4

    Participate

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