Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01385150
Recruitment Status : Completed
First Posted : June 29, 2011
Last Update Posted : May 19, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

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.

Condition or disease Intervention/treatment
Leukemia Genetic: mutation analysis Genetic: protein analysis Other: laboratory biomarker analysis Other: liquid chromatography Other: mass spectrometry

Detailed Description:



  • To determine if serum 2-hydroxyglutarate (2HG) is only detected in acute myeloid leukemia (AML) patients with isocitrate dehydrogenase (IDH) mutations.


  • 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.

Study Type : Observational
Actual Enrollment : 220 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Analysis of Serum 2-Hydroxyglutarate (2HG) Levels, IDH Mutations and Clinical Outcome in Acute Myeloid Leukemia (AML)
Actual Study Start Date : January 3, 2012
Actual Primary Completion Date : February 3, 2012
Actual Study Completion Date : February 3, 2012

Primary Outcome Measures :
  1. Absence of serum 2HG in all samples without an IDH mutation [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Relationship between 2HG level and survival outcomes [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples from patients enrolled on E1900 from whom samples were submitted for research


  • 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


  • Not specified


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01385150

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Courtney DiNardo, MD Abramson Cancer Center of the University of Pennsylvania

Responsible Party: Eastern Cooperative Oncology Group Identifier: NCT01385150     History of Changes
Other Study ID Numbers: CDR0000702952
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017

Keywords provided by Eastern Cooperative Oncology Group:
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
untreated adult acute myeloid leukemia
adult acute basophilic leukemia
adult acute eosinophilic leukemia
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
adult acute minimally differentiated myeloid leukemia (M0)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myelomonocytic leukemia (M4)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type