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

Purpose

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.

Conditions

  • 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

Eligibility

Eligible Ages
Under 22 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Screening
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Screening (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
    • Specimen Collection

Recruiting Locations

MedStar Georgetown University Hospital
Washington, District of Columbia 20007
Contact:
Site Public Contact
202-444-2223

More Details

Status
Recruiting
Sponsor
LLS PedAL Initiative, LLC

Study Contact

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, 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.