Matched Targeted Therapy For High-Risk Leukemias and Myelodysplastic Syndrome
Recurrent, Refractory, or High Risk Leukemias, Matched Targeted Therapy
About this trial
This is an interventional diagnostic trial for Recurrent, Refractory, or High Risk Leukemias focused on measuring Recurrent, Refractory, or High Risk Leukemias, Matched targeted therapy
Eligibility Criteria
Inclusion Criteria:
- Birth to ≤ 30 years at study entry
- Diagnosis: Patients will be enrolled in one of the two cohorts based on diagnosis:
Cohort 1: Relapsed/refractory leukemia
- Acute lymphoblastic leukemia, first or greater relapse
- Acute myeloid leukemia, first or greater relapse
- Leukemia refractory to induction chemotherapy
- Other recurrent leukemia
- Myelodysplastic syndrome (MDS), first or greater relapse, or refractory to initial therapy
Cohort 2: New diagnosis
- Acute myeloid leukemia, new diagnosis
- New diagnosis infant MLL-rearranged ALL or low hypodiploid (<40 chromosomes) ALL
- Rare leukemia- e.g., JMML, leukemia of ambiguous lineage
- Secondary leukemia
- Myelodysplastic syndrome (MDS) not eligible for stem cell transplant
Pathologic Criteria
- Histologic confirmation of leukemia at the time of diagnosis or recurrence
Specimen Samples
- Sufficient leukemia specimen available for profiling from diagnosis or recurrence OR bone marrow aspirate/blood draw/pheresis/other fresh sample of patient leukemia cells planned for clinical care anticipated to allow collection of minimum specimen for testing.
Exclusion Criteria:
- Insufficient leukemia specimen available for profiling from diagnosis or recurrence; or bone marrow evaluation/blood draw/other leukemia cell sample NOT planned to be obtained for clinical care; or peripheral blast percentage <20% AND clinical blood draw not planned.
Sites / Locations
- UCSF Helen Diller Family Comprehensive Cancer Center
- Children's Hospital Colorado
- Children's Healthcare of Atlanta
- The University of Chicago
- Johns Hopkins Hospital
- Dana Farber Cancer Institute
- Children's Hospital's and Clinics of Minnesota
- Washington University at St. Louis School of Medicine
- The Children's Hospital at Montefiore
- Roswell Park Comprehensive Cancer Center
- Columbia University Medical Center
- Memorial Sloan Kettering Cancer Center
- Children's Hospital of Philadelphia
- Seattle Children's Hospital
- Children's Hospital of Wisconsin
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Relapsed/Refractory Leukemia
New Diagnosis
Cohort 1: Relapsed/Refractory Leukemia Acute lymphoblastic leukemia (ALL), first or greater relapse Acute myeloid leukemia (AML), first or greater relapse Leukemia refractory to induction chemotherapy Other recurrent leukemia Myelodysplastic syndrome (MDS), first or greater relapse, or refractory to initial therapy After the screening procedures confirms patient eligibility: Leukemia Profiling will be performed Identifying an actionable genomic alteration and making a matched targeted therapy treatment recommendation.
Cohort 2: New Diagnosis Acute myeloid leukemia (AML), new diagnosis (excluding acute promyelocytic leukemia (APL)) New diagnosis infant mixed-lineage leukemia (MLL)-rearranged ALL or low hypodiploid (<40 chromosomes) ALL Rare leukemia- e.g., juvenile myelomonocytic leukemia (JMML), leukemia of ambiguous lineage Secondary leukemia Myelodysplastic syndrome (MDS) not eligible for stem cell transplant After the screening procedures confirms eligibility: Leukemia Profiling will be performed Identifying an actionable genomic alteration and making a matched targeted therapy treatment recommendation.