S0106A, Biomarkers in Samples From Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Cytarabine-Based Chemotherapy
Condition: Leukemia
MeSH terms: Leukemia
Study type: Observational

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.
    

Intervention name(s): proteomic profiling; flow cytometry; laboratory biomarker analysis
Intervention type(s): Genetic; Other; Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients enrolled in S0106 that consented to use of specimens for future reserach
      
Keywords: adult acute basophilic leukemia; adult acute eosinophilic leukemia; adult acute erythroid leukemia (M6); adult acute megakaryoblastic leukemia (M7); adult acute minimally differentiated myeloid leukemia (M0); 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)