Leukemia Clinical Trial
Official title:
Validation of a Classifier for the Prediction of Risk of Relapse Using Single Cell Network Profiling (SCNP) Assays for Childhood AML
RATIONALE: A screening test, such as My Profile Pediatric Assay, may help doctors predict a
patient's risk of relapse and plan better treatment for acute myeloid leukemia.
PURPOSE: This clinical trial is studying using the My Profile Pediatric Assay to see how
well it works in predicting risk of relapse in bone marrow cell samples from younger
patients with acute myeloid leukemia.
OBJECTIVES:
Primary
- To validate the accuracy of the My Profile Pediatric Assay to predict risk of relapse
in pediatric patients with non-M3 acute myeloid leukemia (AML) who responded to
cytarabine-based induction chemotherapy.
Secondary
- To validate the continuous score from the pre-specified classifier as a predictor of
relapse after response to induction chemotherapy, while controlling for the
simultaneous effects of the following clinical and laboratory variables: age, WBC,
ethnicity, cytogenetics, Flt3-ITD, NPM1, MRD, and bone marrow (BM) donor availability.
- To validate the accuracy of the prespecified low versus high relapse indicator variable
(I_L/H) as a predictor of relapse after induction therapy.
- To validate the accuracy of the prespecified I_L/H as a predictor of relapse after
induction therapy, while controlling for the simultaneous effects of the following
clinical and laboratory variables: MRD, age, WBC, ethnicity, cytogenetics, Flt3-ITD,
NPM1, and BM donor availability.
OUTLINE: Archived bone marrow mononuclear cells are analyzed by single cell network profile
assay, the My Profile™ AML Risk of Relapse Assay. Molecular markers analyzed include
Flt3-ITD, NPM1, and MRA. Results are then correlated with each patient's clinical data
including patient's age, race/ethnic background, gender, treatment received, and outcomes.
;
Observational Model: Cohort, Time Perspective: Retrospective
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