Active, currently enrolling
Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias
NCT No.: NCT04726241
Study Type: INTERVENTIONAL
Phase:
Phase I
Region: California - Northern
Acronym: (PedAL)
Official Title
Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias
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.
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 from relapse in children and young adults with recurrent and refractory leukemia.
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.
Eligibility Criteria
Inclusion Criteria
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• 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
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Exclusion Criteria
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Please contact study team for exclusion criteria.
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Keywords and/or Specific Medical Conditions
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Immunoproliferative Disorders
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Lymphoproliferative Disorders
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Neoplasms by Histologic Type
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
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Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
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Sponsors
- Children's Oncology Group
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