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
S
Sandeep Batra, MD
Primary Investigator
Overview
This study aims to use clinical and biological characteristics of acute leukemias to screengibility 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 treaty 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 inhildren, adolescents, and young adults.
Description
PRIMARY OBJECTIVES:
I. To utilize clinical and biological characteristics of acute leukemias to screen forgibility for available phase I/II Pediatric Acute Leukemia (PedAL) sub-trials.
II. To maintain a longitudinal and comprehensive registry from relapse in children and youngdults with recurrent and refractory leukemia.
TLINE
Patients undergo collection of blood and/or bone marrow samples at baseline, end of treatmentycle(s), and at relapse/refractory disease status (if applicable).
After completion of study, patients are followed up every 3 months for 2 years, and thenvery 6 months for 3 years.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent B Acute Lymphoblastic Leukemia, Recurrent Mixed Phenotype Acute Leukemia, Recurrent T Acute Lymphoblastic Leukemia, Refractory Acute Myeloid Leukemia, Refractory Mixed Phenotype Acute Leukemia, Therapy-Related Acute Myeloid Leukemia
-
Age: - 22 Years
-
Gender: All
Inclusion Criteria:
- Patients must be less than 22 years of age at the time of study enrollment
- Patient must have one of the following:
- Patient has known or suspected relapsed/refractory (including primary refractory)
AML
- This includes isolated myeloid sarcoma
- Patient has known or suspected relapsed/refractory (including primary refractory)
myeloid leukemia of Down syndrome
- Patient has known or suspected relapsed ALL that meets one of the following
- 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
- Patient has known or suspected de novo or relapsed/refractory (including primaryy) treatment related AML
- Patient has known or suspected relapsed/refractory (including primary refractory)
AML
- 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
Updated on
28 Apr 2024.
Study ID: APAL2020SC
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