Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01385150
First received: June 28, 2011
Last updated: July 7, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Leukemia
Genetic: mutation analysis
Genetic: protein analysis
Other: laboratory biomarker analysis
Other: liquid chromatography
Other: mass spectrometry

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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Absence of serum 2HG in all samples without an IDH mutation [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationship between 2HG level and survival outcomes [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: August 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   17 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385150

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Principal Investigator: Courtney DiNardo, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT01385150     History of Changes
Other Study ID Numbers: CDR0000702952, ECOG-E1900T8
Study First Received: June 28, 2011
Last Updated: July 7, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 29, 2014