Validation of a Classifier for the Prediction of Risk of Relapse Using Single Cell Network Profiling (SCNP) Assays for Childhood AML
N/A
21 Years
Both
Leukemia
Trial Information
Validation of a Classifier for the Prediction of Risk of Relapse Using Single Cell Network Profiling (SCNP) Assays for Childhood AML
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Patients with confirmed non-M3 acute myeloid leukemia
- Treated on COG-AAML03P1 or COG- AAML0531 protocols
- Samples from COG-AAML0531 can come from either treatment arm, but these
samples need to be independent from any patients who donated samples
assayed in study COG-AAML11B2
- Patients with Down syndrome are excluded
- Cryopreserved bone marrow mononuclear cell (BMMC) samples collected at diagnosis,
prior to start induction therapy
- Samples must have been cryopreserved at central lab within 3 days of draw at
clinical site
- Target of 10 X 10^6 cells frozen
- Patients' clinical annotations required after unblinding
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Area under the receiver operating characteristic (ROC) curve of continuous score from the pre-specified classifier in predicting relapse after complete response to cytarabine- based induction chemotherapy
Outcome Description:
A logistic regression model and area under the ROC curve for the model will be tested for significance against a null value of 0.5.
Outcome Time Frame:
Up to 3 years
Safety Issue:
No
Principal Investigator
Norman J. Lacayo, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Stanford University
Authority:
United States: Institutional Review Board
Study ID:
AAML11B12
NCT ID:
NCT01438138
Start Date:
September 2011
Completion Date:
Related Keywords:
- Leukemia
- childhood acute myeloid leukemia in remission
- recurrent childhood acute myeloid leukemia
- untreated childhood acute myeloid leukemia and other myeloid malignancies
- childhood acute basophilic leukemia
- childhood acute eosinophilic leukemia
- childhood acute erythroleukemia (M6)
- childhood acute megakaryocytic leukemia (M7)
- childhood acute monoblastic leukemia (M5a)
- childhood acute monocytic leukemia (M5b)
- childhood acute myeloblastic leukemia with maturation (M2)
- childhood acute myeloblastic leukemia without maturation (M1)
- childhood acute myelomonocytic leukemia (M4)
- childhood acute minimally differentiated myeloid leukemia (M0)
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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