RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
Up to 22 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years, 3 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "After completion of study, patients are followed up every 3 months for 2 years, and then every 6 months for 3 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests bone marrow and blood to help find other leukemia studies patients may qualify for. It is for people younger than 22 with certain leukemias or related blood diseases, including cancer that has come back or is hard to treat.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be younger than 22 when you join and have one of the confirmed or suspected diseases listed below.
  • AML, a fast-growing blood cancer; myeloid leukemia linked to Down syndrome; or mixed phenotype acute leukemia, which has features of more than one leukemia type. The disease must have come back or resisted treatment. AML may include a tumor of leukemia cells outside the bone marrow.
  • ALL, another fast-growing blood cancer, that has returned in the bone marrow: B-ALL must have returned at least twice, or at least once if it has a KMT2A gene change. T-ALL must have returned at least once, with or without this gene change.
  • AML caused by earlier treatment, either newly diagnosed, back after treatment, or resistant to treatment.
  • Myelodysplastic syndrome (MDS), in which bone marrow makes abnormal blood cells, including MDS caused by earlier treatment. It may be newly diagnosed, unchanged or growing despite treatment, or back after treatment.
  • Juvenile myelomonocytic leukemia (JMML), a blood cancer, that is newly diagnosed, unchanged or growing despite treatment, or back after treatment.
  • You and/or your parent or legal guardian must sign a form agreeing to take part.
  • All study rules set by the hospital, the Food and Drug Administration, and the National Cancer Institute must be met.

Who can't join

    Simplified for readability. The official criteria below are what the study team uses.

    Official eligibility 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 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

    Study sites (164)

    AK

    AL

    AR

    AZ

    CA

    CO

    CT

    DC

    DE

    FL

    GA

    HI

    • Kapiolani Medical Center for Women and Children · Honolulu, HI 96826Site Public Contact · Study contact · 808-983-6090Wade T. Kyono · Principal investigatorMore trials in Honolulu

    IA

    ID

    IL

    IN

    KY

    LA

    MA

    • Dana-Farber Cancer Institute · Boston, MA 02215Site Public Contact · Study contact · 877-442-3324Jessica A. Pollard · Principal investigatorMore trials in Boston

    MD

    ME

    MI

    MN

    MO

    MS

    • University of Mississippi Medical Center · Jackson, MS 39216Site Public Contact · Study contact · 601-815-6700Amanda Strobel · Principal investigatorMore trials in Jackson

    NC

    ND

    NE

    NH

    NJ

    NM

    NV

    NY

    OH

    OK

    OR

    PA

    RI

    SC

    SD

    TN

    TX

    UT

    VA

    WA

    WI

    WV