Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia

Eastern Cooperative Oncology Group

Status: Completed

Conditions: Leukemia

Treatments: Genetic: protein analysis; Genetic: mutation analysis; Other: laboratory biomarker analysis; Other: mass spectrometry; Other: liquid chromatography

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01385150

ECOG-E1900T8

CDR0000702952

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 17 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Morphologically confirmed acute myeloid leukemia (AML)

  • Newly diagnosed with AML
  • Serum samples from patients enrolled on the ECOG-1900 clinical trial between 2002 and 2008
  • Patients with or without isocitrate dehydrogenase (IDH) mutations

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Received 2 different doses of standard induction chemotherapy on ECOG-1900