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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Leukemia

Intervention / Treatment
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* Genetic: proteomic profiling
* Other: flow cytometry
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Newly diagnosed non-M3 acute myeloid leukemia (AML) Pretreatment and relapsed and/or refractory cryopreserved bone marrow mononuclear cells (BMMCs) and peripheral blood mononuclear cells (PBMCs) available Have 2+ vials of pretreatment marrow cells and/or 2+ vials of pretreatment PBMCs in the Southwestern Oncology Group (SWOG) AML/Myelodysplastic Syndrome (MDS) Repository Usable samples must contain approximately 1.6 ×10^6 cluster of differentiation antigen 45+ (CD45+) cells post thaw. Eligible and evaluable patients who participated on SWOG-S0106 study PATIENT CHARACTERISTICS: Did not refuse consent for this use of specimens PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: proteomic profiling|nan|
|Other: flow cytometry|nan|
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to induction chemotherapy (complete response vs non-complete response) (classifier 1) |  | immediate | 
| CCR1 at 1 year (classifier 2) |  | immediate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult acute eosinophilic leukemia, adult acute erythroid leukemia (M6), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute basophilic leukemia, adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with del(5q), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myelomonocytic leukemia (M4)