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NCT Number: NCT01385150

Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia

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.

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Key information

Conditions

Leukemia Bone Marrow Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hematologic Diseases Hemic and Lymphatic Diseases Leukemia, Basophilic, Acute Leukemia, Eosinophilic, Acute Leukemia, Erythroblastic, Acute Leukemia, Monocytic, Acute Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelomonocytic, Acute Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

17 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mutation analysis

Genetic

protein analysis

Genetic

laboratory biomarker analysis

Other

liquid chromatography

Other

mass spectrometry

Other

Primary outcomes

  1. Absence of serum 2HG in all samples without an IDH mutation

    Time frame: 1 day

Secondary outcomes

  1. Relationship between 2HG level and survival outcomes

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Eastern Cooperative Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 29, 2011
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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