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