Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01385150

Enrollment

220

Registered

2011-06-29

Start date

2012-01-03

Completion date

2012-02-03

Last updated

2017-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

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)

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.

Interventions

GENETICmutation analysis

GENETICprotein analysis

OTHERlaboratory biomarker analysis

OTHERliquid chromatography

OTHERmass spectrometry

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

17 Years to 60 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Absence of serum 2HG in all samples without an IDH mutation	1 day

Secondary

Measure	Time frame
Relationship between 2HG level and survival outcomes	1 day

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026