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Validation of a Classifier for the Prediction of Risk of Relapse Using Single Cell Network Profiling (SCNP) Assays for Childhood AML


N/A
N/A
21 Years
Open (Enrolling)
Both
Leukemia

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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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