IRB Study Number 23-009
Status Recruiting
Institute Taussig Cancer Institute
Description
Primary Aims
1.1.1 To utilize clinical and biological characteristics of acute leukemias to screen for patient eligibility for available Phase I/II PedAL sub-trials.
1.1.2 To maintain a longitudinal and comprehensive registry, as well as a specimen bank, from relapse in children and young adults with acute leukemias.
Inclusion Criteria
3.2.1 Age
Patients must be less than 22 years of age at the time of study enrollment.
3.2.2 Diagnosis
Patient must have one of the following at the time of study enrollment: (See Section 9.3 for definitions of relapse and refractory disease)
a. Patient has known or suspected relapsed/refractory (including primary refractory) AML as defined in Section 9.3.
• This includes isolated myeloid sarcoma.
b. Patient has known or suspected relapsed/refractory (including primary refractory) myeloid leukemia of Down syndrome (ML-DS).
c. Patient has known or suspected relapsed ALL as defined in Section 9.3 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.
d. Patient has known or suspected relapsed/refractory (including primary refractory) mixed phenotype acute leukemia (MPAL) as defined in Section 9.3.
e. Patient has known or suspected de novo or relapsed/refractory (including primary refractory) treatment-related AML (t-AML).
f. Patient has known or suspected de novo or relapsed/refractory (including primary refractory) Myelodysplastic Syndrome (MDS or treatment-related Myelodysplastic Syndrome (t-MDS). See Appendix IV for additional information. 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). See Appendix V for additional information. Note: Relapsed/refractory disease includes Stable Disease, Progressive Disease, and Disease Relapse.
Exclusion Criteria
Exclusion Criteria Not Available
