Spots Global Cancer Trial Database for Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia

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Trial Identification

Brief Title: Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia

Official Title: Analysis of Serum 2-Hydroxyglutarate (2HG) Levels, IDH Mutations and Clinical Outcome in Acute Myeloid Leukemia (AML)

Study ID: NCT01385150

Conditions

Leukemia

Interventions

mutation analysis

protein analysis

laboratory biomarker analysis

liquid chromatography

mass spectrometry

Study Description

Brief Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify and lean more about biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in blood samples from patients with acute myeloid leukemia.

Detailed Description: OBJECTIVES: Primary * To determine if serum 2-hydroxyglutarate (2HG) is only detected in acute myeloid leukemia (AML) patients with isocitrate dehydrogenase (IDH) mutations. Secondary * To determine if the level of serum 2HG impacts leukemia-free survival (LFS). * To determine if the level of serum 2HG impacts overall survival (OS). * To determine if serum 2HG is undetectable at the time of documented clinical remission (CR) in IDH-mutated patients. OUTLINE: Archived serum samples are analyzed for 2-hydroxyglutarate expression by reverse-phase liquid chromatography coupled to mass spectrometry. Results are then compared with presence or absence of an IDH mutation, patients' clinical outcome, as well as age, sex, white blood cell count at diagnosis, platelet count, bone marrow blast percentage at diagnosis, circulating (serum) percentage at diagnosis, cytogenetic risk group, presence of FLT3, NPMN1, and/or TET2 mutations, specific IDH mutation, and randomization treatment group allocation.