S9031-S9333-S0112-S0301-A Biomarkers Associated With Response to Cytarabine in Samples From Older Patients With Acute Myeloid Leukemia
NCT ID: NCT01338974
Last Updated: 2015-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
290 participants
OBSERVATIONAL
2011-03-31
2012-08-31
Brief Summary
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PURPOSE: This research trial studies biomarkers associated with response to cytarabine in samples from older patients with acute myeloid leukemia.
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Detailed Description
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* Refinement and testing of a multiparameter flow cytometry-based cell-signaling signature (FC classifier) associated with in vivo likelihood of complete response (CR) to cytarabine-based induction chemotherapy in elderly patients (56 years and older) newly diagnosed with non-M3 acute myeloid leukemia (AML).
* Identification of cell-signaling signature(s) associated with continuous CR to cytarabine-based induction chemotherapy at one year (CCR1) in adult patients 56 years and older with a newly diagnosed non-M3 AML.
* Identification of cell-signaling signature(s) associated with relapse-free survival at one year (RFS1) in adult patients 56 years and older with a newly diagnosed non-M3 AML who received cytarabine-based induction chemotherapy and achieved CR.
* To investigate changes in cell-signaling signature(s) between matched pre- and post-treatment specimens of relapsed/refractory patients.
OUTLINE: This is a multicenter study.
Cryopreserved specimens are incubated with cytokines (e.g., interleukins), growth factors (e.g., sargramostim or filgrastim), and chemotherapeutic agent (e.g., cytarabine, etoposide) and other modulators. Cells are then fixed, permeabilized, and stained with antibodies that recognize extracellular markers (for example, surface phenotypic markers such as clusters of differentiation, drug transporters, and receptors) in conjunction with intracellular activation-state-specific epitopes of designated signaling molecules. Subsequently, cell are analyzed by phospho-flow cytometry (FC) in a random manner (without knowledge of clinical variables and outcomes) to a training set (complete pre-specified FC) versus a testing set. Cells are also analyzed by proteomic assays. Results are then compared with individual patient scores, including predicted clinical outcomes.
Conditions
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Study Design
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RETROSPECTIVE
Interventions
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gene expression analysis
proteomic profiling
flow cytometry
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* Have 2+ vials of pretreatment marrow cells and/or 2+ vials of pretreatment peripheral blood cells in the Southwest Oncology Group (SWOG) AML/MDS Repository
PATIENT CHARACTERISTICS:
* See Disease Characteristics
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
56 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Jerry Radich, MD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
References
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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.
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.
Other Identifiers
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S9031-S9333-S0112-S0301-A
Identifier Type: OTHER
Identifier Source: secondary_id
S9031-S9333-S0112-S0301-A
Identifier Type: -
Identifier Source: org_study_id
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