Trial Information

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

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.