Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias
Pediatric Acute Leukemia (PedAL) Screening Trial - Developing New Therapies for Relapsed Leukemias
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Clinical Trial Information
Trial Contact: Armatti, Julie M; Parker, Melanie; Torrescano, Tanner; Frankos, Marie; Singh, Sarah H; Jones, Jamie
Trial Phone: 321-843-5284 ; 321-843-1036 ; 321-841-8271 ; 321-842-8738 ; 321.841.7561 ; 3218412008
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IRB No: C25.019.01
Protocol Abbrev: APAL2020SC
Principal Investigator: Jaime C Gonzalez, MD
Age Group: Pediatric
Secondary Protocol No: APAL2020SC
Treatment: Procedure: Biospecimen Collection
Therapies Involved: Procedural
ClinicalTrials.gov ID: NCT04726241
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Objective
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. -
Key Eligibility
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.
