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


N/A
17 Years
60 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

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


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.

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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Absence of serum 2HG in all samples without an IDH mutation

Safety Issue:

No

Principal Investigator

Courtney DiNardo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

Unspecified

Study ID:

CDR0000702952

NCT ID:

NCT01385150

Start Date:

August 2011

Completion Date:

Related Keywords:

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

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