Completed

NCT Number: NCT01438138

Study to Predict Risk of Relapse in Bone Marrow Cell Samples From Younger Patients With Acute Myeloid Leukemia

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.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia, Eosinophilic, Acute Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diagnostic laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

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

Time frame: Up to 3 years

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.

Secondary outcomes

Continuous score from the pre-specified classifier as a predictor of relapse after response to induction chemotherapy

Time frame: Up to 3 years

A gate-keeper strategy will be applied to control the experiment-wise type I error rate at 0.05. The null hypothesis will be tested using a likelihood ratio test that will compare the likelihood for a full (LF) and a reduced (LR) logistic regression model of relapse (early relapse vs continuous complete response), where the full model will include the covariates and the continuous score from the pre-specified classifier and the reduced model will include only the covariates.

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Sep 21, 2011
Registry last updated: May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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