Pediatric Acute Leukemia (PedAL) Screening Trial: Developing New Therapies for Relapsed Leukemias.
1.To utilize clinical and biological characteristics of acute leukemias to screen for
patient eligibility for available Phase I/II PedAL sub-trials.
2.To maintain a longitudinal and comprehensive registry from relapse in children
and young adults with recurrent and refractory leukemia.
- RWJBarnabas Health
- Newark Beth Israel Medical Center
- Robert Wood Johnson University Hospital, New Brunswick
- Rutgers University
- other
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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.