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

a study on Acute Lymphoblastic Leukemia Leukemia Acute Myeloid Leukemia Juvenile Myelomonocytic Leukemia Myelodysplastic Syndrome Down Syndrome Lymphoma

Summary

Eligibility
for people ages up to 22 years (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Jennifer G. Michlitsch (ucsf)Elliot Stieglitz (ucsf)
Headshot of Jennifer G. Michlitsch
Jennifer G. Michlitsch
Headshot of Elliot Stieglitz
Elliot Stieglitz

Description

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.

Official Title

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

Details

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.

II. 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.

Keywords

Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Acute Myeloid Leukemia Post Cytotoxic Therapy, Juvenile Myelomonocytic Leukemia, Mixed Phenotype Acute Leukemia, Myelodysplastic Syndrome, Myelodysplastic Syndrome Post Cytotoxic Therapy, Myeloid Leukemia Associated With Down Syndrome, Leukemia, Myeloid Leukemia, Leukemia, Myeloid, Acute, Preleukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelomonocytic, Juvenile, Down Syndrome, Myelodysplastic Syndromes, Syndrome, Acute Disease, Biospecimen Collection

Eligibility

For people ages up to 22 years

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

Locations

  • UCSF Benioff Children's Hospital Oakland accepting new patients
    Oakland California 94609 United States
  • UCSF Medical Center-Mission Bay accepting new patients
    San Francisco California 94158 United States
  • Rady Children's Hospital - San Diego not yet accepting patients
    San Diego California 92123 United States
  • Children's Hospital Los Angeles accepting new patients
    Los Angeles California 90027 United States
  • Children's Hospital of Orange County accepting new patients
    Orange California 92868 United States
  • Kaiser Permanente-Oakland accepting new patients
    Oakland California 94611 United States
  • Valley Children's Hospital accepting new patients
    Madera California 93636 United States
  • Kaiser Permanente Downey Medical Center accepting new patients
    Downey California 90242 United States
  • Miller Children's and Women's Hospital Long Beach accepting new patients
    Long Beach California 90806 United States
  • Lucile Packard Children's Hospital Stanford University accepting new patients
    Palo Alto California 94304 United States

Lead Scientists at University of California Health

  • Jennifer G. Michlitsch (ucsf)
    Professor, Pediatrics, School of Medicine. Authored (or co-authored) 23 research publications
  • Elliot Stieglitz (ucsf)
    Juvenile myelomonocytic leukemia (JMML) is a blood cancer that affects young children and is difficult to diagnose. Currently available therapies cure only half of patients, with some children experiencing an aggressive disease course while some children get better with very little treatment. We have now shown that the presence of secondary mutations at diagnosis predicts a poor outcome.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
LLS PedAL Initiative, LLC
ID
NCT04726241
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 960 study participants
Last Updated