Matched Targeted Therapy For High-Risk Leukemias and Myelodysplastic Syndrome

Running, not enrolling · Not applicable

Conditions studied: Recurrent, Refractory, or High Risk Leukemias, Matched Targeted Therapy

In brief

This research study is seeking to gain new knowledge about Recurrent, Refractory, or High Risk Leukemias in children and young adults. This study is evaluating the use of specialized testing called leukemia profiling. Once the profiling is performed, the results are evaluated by an expert panel of physicians, scientists and pharmacists. This may result in a recommendation for a specific cancer therapy or a clinical trial called matched targeted therapy (MTT). The results of the leukemia profiling and, if applicable, the MTT recommendation will be communicated to the participant's primary oncologist.

Key facts

Study ID

NCT02670525

Run by

Dana-Farber Cancer Institute

People needed

338

Starts

2016-08-17

Expected to finish

2028-01-31

Last updated by the study team

2026-08-06

Who can join

Age: any, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 (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
• Cohort 2: New diagnosis
• Acute myeloid leukemia (AML), new diagnosis
• 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
• 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.

You may not qualify if…

• 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.

Where it is running

• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• The University of Chicago — Chicago, Illinois, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Children's Hospital's and Clinics of Minnesota — Minneapolis, Minnesota, United States
• Washington University at St. Louis School of Medicine — St Louis, Missouri, United States
• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• The Children's Hospital at Montefiore — The Bronx, New York, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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