Status:
RECRUITING
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
Lead Sponsor:
PedAL BCU, LLC
Collaborating Sponsors:
Children's Oncology Group
National Cancer Institute (NCI)
Conditions:
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Eligibility:
All Genders
Up to 22 years
Phase:
PHASE1
PHASE2
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 pati...
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. I...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
960 Patients enrolled
Trial Details
Trial ID
NCT04726241
Start Date
April 18 2022
End Date
December 31 2028
Last Update
October 20 2025
Active Locations (181)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
USA Health Strada Patient Care Center
Mobile, Alabama, United States, 36604
3
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
4
Banner Children's at Desert
Mesa, Arizona, United States, 85202