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Validation of a Classifier for Induction Response Prediction 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 Induction Response Prediction Using Single Cell Network Profiling (SCNP) Assays for Childhood AML


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-AAML05331 studies.

Molecular markers analyzed include Flt3ITD, NPM1, CEBPA, and MRA.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of acute myeloid leukemia (AML)

- Non-M3 AML

- Cryopreserved bone marrow mononuclear cell specimens from patients enrolled on
COG-AAML03P1 and COG-AAML05331 collected prior to cytarabine-based induction therapy

- Patient samples from COG-AAML0531 must come from the control arm (i.e., no
gemtuzumab ozogamicin induction therapy)

PATIENT CHARACTERISTICS:

- No Down syndrome

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Accuracy of induction response prediction

Safety Issue:

No

Principal Investigator

Norman J. Lacayo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Federal Government

Study ID:

CDR0000697455

NCT ID:

NCT01321385

Start Date:

March 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 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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