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

This study is not yet open for participant recruitment.
Verified October 2011 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01438138
First received: September 17, 2011
Last updated: October 20, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention
Leukemia
 Genetic: proteomic profiling
Other: diagnostic laboratory biomarker analysis
Other: flow cytometry
Other: medical chart review
Other: single cell network profile assay

Study Type: Interventional
Study Design: Primary Purpose: Screening
Official Title: Validation of a Classifier for the Prediction of Risk of Relapse Using Single Cell Network Profiling (SCNP) Assays for Childhood AML

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Validation of My Profile Pediatric Assay [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • My Profile Pediatric Assay and patients' clinical data as predictive of disease relapse after response to induction chemotherapy [ Designated as safety issue: No ]

Estimated Enrollment: 98
Study Start Date: September 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438138

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Norman J. Lacayo, MD Stanford University
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01438138     History of Changes
Other Study ID Numbers: CDR0000711851, COG-AAML11B12
Study First Received: September 17, 2011
Last Updated: October 20, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013