S0106A, Biomarkers in Samples From Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Cytarabine-Based Chemotherapy

NCT ID: NCT01360125

Last Updated: 2016-04-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 310 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2015-12-31

Brief Summary

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

PURPOSE: This research study studies biomarkers in samples from patients with newly diagnosed acute myeloid leukemia treated with cytarabine-based chemotherapy.

Detailed Description

OBJECTIVES:

• Training and testing of multiparameter flow cytometry-based cell signaling signature (FC classifier 1) associated with in vivo primary chemoresistance (i.e., non-complete response [NR]) to standard induction therapy in adult patients ≤ 60 years old with a newly diagnosed non-M3 acute myeloid leukemia (AML).
• Training and testing of multiparameter flow cytometry-based cell signaling signature (FC classifier 2) associated with complete continuous response at 1 year (CCR1) in adult patients ≤ 60 years old with a newly diagnosed non-M3 AML who are treated with cytarabine-based induction chemotherapy.
• Identification of signaling signature(s) associated with secondary chemoresistance (i.e., disease relapse) in adult patients ≤ 60 years of age who have longitudinally paired peripheral blood mononuclear cells (PBMC) or bone marrow mononuclear cells (BMMC) samples at diagnosis and at the time of first relapse. (Exploratory)

OUTLINE: Cryopreserved samples are incubated with cytokines (e.g., interleukins), growth factors (e.g., sargramostim [GM-CSF] and filgrastim [G-CSF]), chemotherapeutic agents (e.g., cytarabine, etoposide phosphate), and other modulators. Cells are fixed, permeabilized, and stained with antibodies that recognize extracellular markers in conjunction with intracellular activation-state specific epitopes of designated signaling molecules. Subsequently, cells are analyzed for multiparametric phospho-flow cytometry in a random manner (without knowledge of clinical variables and outcomes) to training and testing sets. Results are then compared with individual patient clinical outcomes.

Conditions

Leukemia

Study Design

• Study Time Perspective: RETROSPECTIVE

Interventions

proteomic profiling

Intervention Type: GENETIC

flow cytometry

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS:

• Did not refuse consent for this use of specimens

PRIOR CONCURRENT THERAPY:

• Not specified

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerry Radich, MD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

References

Medeiros BC, Othus M, Fang M, Appelbaum FR, Erba HP. Cytogenetic heterogeneity negatively impacts outcomes in patients with acute myeloid leukemia. Haematologica. 2015 Mar;100(3):331-5. doi: 10.3324/haematol.2014.117267. Epub 2014 Dec 19.

Reference Type: DERIVED

PMID: 25527568 (View on PubMed)

Medeiros BC, Othus M, Estey EH, Fang M, Appelbaum FR. Unsuccessful diagnostic cytogenetic analysis is a poor prognostic feature in acute myeloid leukaemia. Br J Haematol. 2014 Jan;164(2):245-50. doi: 10.1111/bjh.12625. Epub 2013 Oct 28.

Reference Type: DERIVED

PMID: 24383844 (View on PubMed)

Other Identifiers

S0106A

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

S0106A

Identifier Type: -

Identifier Source: org_study_id