Leukemia Clinical Trial
Official title:
Validation of a Classifier for Induction Response Prediction Using Single Cell Network Profiling (SCNP) Assays for Childhood AML
RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may
help doctors predict how well patients will respond to treatment.
PURPOSE: This research trial is studying biomarkers in predicting response to treatment in
bone marrow samples from young patients with acute myeloid leukemia.
OBJECTIVES:
Primary
- To validate the accuracy of a pre-specified acute myeloid leukemia (AML) induction
response classifier or the My Profile™ AML Induction Therapy Assay (run in a Good
Laboratory Practice [GLP] laboratory using Good Manufacturing Practice [GMP] reagents)
in predicting response to cytarabine-based induction chemotherapy in pediatric patients
with non-M3 AML.
Secondary
- To validate the continuous score from the pre-specified induction response classifier
as a predictor of response to induction chemotherapy, after controlling for the
simultaneous effects of clinical variables at base-line and/or pre-induction therapy
(e.g., age, WBC, and percentage [%] of blasts), and tests commonly available after the
start of induction therapy (e.g., cytogenetics and molecular markers).
- To validate the accuracy of the pre-specified induction response classifier as a binary
predictor of induction response using a pre-specified cutpoint to assign patients to no
response (NR) or complete response (CR) groups.
- To validate the accuracy of the pre-specified induction response classifier as a binary
predictor of induction response using a pre-specified cutpoint to assign patients to NR
or CR groups, after controlling for the simultaneous effects of clinical variables at
base-line (pre-induction therapy) (e.g., age, WBC, % blasts) and clinical variables,
including tests commonly available after start of induction therapy (e.g., age, WBC,
cytogenetics).
OUTLINE: Cryopreserved bone marrow mononuclear cell specimens are analyzed by cell
networking profiling assays. Results are then compared with patient outcomes and
demographics from COG-AAML03P1 and COG-AAML0531 studies.
Molecular markers analyzed include Flt3ITD, NPM1, CEBPA, and MRA.
;
Observational Model: Cohort, Time Perspective: Retrospective
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