Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Leukemia

Intervention / Treatment
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* Genetic: mutation analysis
* Genetic: protein analysis
* Other: laboratory biomarker analysis
* Other: liquid chromatography
* Other: mass spectrometry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: mutation analysis|nan|
|Genetic: protein analysis|nan|
|Other: laboratory biomarker analysis|nan|
|Other: liquid chromatography|nan|
|Other: mass spectrometry|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of serum 2HG in all samples without an IDH mutation |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between 2HG level and survival outcomes |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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)