- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01385150
Biomarkers in Blood Samples From Patients With Acute Myeloid Leukemia
Analysis of Serum 2-Hydroxyglutarate (2HG) Levels, IDH Mutations and Clinical Outcome in Acute Myeloid Leukemia (AML)
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Absence of serum 2HG in all samples without an IDH mutation
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relationship between 2HG level and survival outcomes
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Courtney DiNardo, MD, Abramson Cancer Center of the University of Pennsylvania
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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 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)
- adult acute basophilic leukemia
- adult acute eosinophilic leukemia
- adult erythroleukemia (M6a)
- adult pure erythroid leukemia (M6b)
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000702952
- ECOG-E1900T8
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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