Clinical trial NCT01385150: Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia
Official title: Analysis of Serum 2-Hydroxyglutarate (2HG) Levels, IDH Mutations and Clinical Outcome in Acute Myeloid Leukemia (AML)
Study type: OBSERVATIONAL
Overall status: COMPLETED
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)
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-06-29
Enrollment: 220
Sex: ALL
Minimum age (years): 17
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from patients enrolled on E1900 from whom samples were submitted for research

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.

Eligibility 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

Primary outcomes:
measure: Absence of serum 2HG in all samples without an IDH mutation
timeFrame: 1 day
Secondary outcomes:
measure: Relationship between 2HG level and survival outcomes
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Courtney DiNardo, MD
role: PRINCIPAL_INVESTIGATOR
References: