S0106A, Biomarkers in Samples From Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Cytarabine-Based Chemotherapy
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|ClinicalTrials.gov Identifier: NCT01360125|
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : April 15, 2016
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.
|Condition or disease||Intervention/treatment|
|Leukemia||Genetic: proteomic profiling Other: flow cytometry Other: laboratory biomarker analysis|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||310 participants|
|Official Title:||S0106A, Proteomic Signatures Associated With Complete Response (CR) and Complete Continuous Response at One Year (CCR1) Following Cytarabine-Based Induction Chemotherapy in Younger Adult Patients (18-60 Years of Age) With a Newly Diagnosed Non-M3 AML|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
- Response to induction chemotherapy (complete response vs non-complete response) (classifier 1) [ Time Frame: immediate ]
- CCR1 at 1 year (classifier 2) [ Time Frame: immediate ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360125
|Principal Investigator:||Jerry Radich, MD||Fred Hutchinson Cancer Research Center|