Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01385150
• Other study ID #: CDR0000702952
• Secondary ID: ECOG-E1900T8
• Status: Completed
• Phase: N/A
• First received: June 28, 2011
• Last updated: May 18, 2017
• Start date: January 3, 2012
• Est. completion date: February 3, 2012

Study information

• Verified date: May 2017
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: February 3, 2012
• Est. primary completion date: February 3, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Genetic:
• mutation analysis

• protein analysis

Other:
• laboratory biomarker analysis

• liquid chromatography

• mass spectrometry

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of serum 2HG in all samples without an IDH mutation		1 day
Secondary	Relationship between 2HG level and survival outcomes		1 day