Biomarkers in Predicting Response to Treatment in Bone Marrow Samples From Young Patients With Acute Myeloid Leukemia

NCT ID: NCT01321385

Last Updated: 2016-05-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 97 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31

Brief Summary

RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.

PURPOSE: This research trial is studying biomarkers in predicting response to treatment in bone marrow samples from young patients with acute myeloid leukemia.

Detailed Description

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-AAML0531 studies.

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

Conditions

Leukemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

laboratory biomarker analysis

Intervention Type: OTHER

study of socioeconomic and demographic variables

Intervention Type: OTHER

Eligibility Criteria

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-AAML0531 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

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Children's Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Norman J. Lacayo, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Other Identifiers

COG-AAML11B8

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-02851

Identifier Type: REGISTRY

Identifier Source: secondary_id

AAML11B8

Identifier Type: OTHER

Identifier Source: secondary_id

AAML11B8

Identifier Type: -

Identifier Source: org_study_id