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Biomarkers in Samples of Bone Marrow From Patients With Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT01290107
Recruitment Status : Completed
First Posted : February 4, 2011
Last Update Posted : May 18, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at bone marrow samples from patients with acute myeloid leukemia.


Condition or disease Intervention/treatment
Leukemia Genetic: DNA analysis Genetic: gene rearrangement analysis Genetic: microarray analysis Genetic: polymerase chain reaction Other: immunological diagnostic method Other: laboratory biomarker analysis

Detailed Description:

OBJECTIVES:

  • To successfully transplant human acute myeloid leukemia (AML) cells into immunocompromised mice for the purpose of expansion of the cells.
  • To harvest the cells and use chromatin immunoprecipitation (ChIP) methods to identify the locations of the protein complexes on the genome.
  • To study the interactions of the Super Elongation Complex (SEC) and Dot1 Complex (DotCom) complexes in human leukemia samples.
  • To compare the genomic targets of the complexes formed by MLL-ENL chimeras to non-MLL-rearranged leukemia samples to normal controls.

OUTLINE: Cryopreserved cells are implanted into NOD SCID gamma mice, expanded, harvested, and studied by chromatin immunoprecipitation (ChIP) methods (using antibodies to ENL, Af9, and AF10). Results are then analyzed by PCR, DNA sequencing, and/or microarray analysis.


Study Type : Observational
Estimated Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MLL Rearrangements in Acute Myeloid Leukemia: A Pilot Project to Expand and Study MLL-ENL in NOD SCID Gamma Mice
Study Start Date : February 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : May 2016





Primary Outcome Measures :
  1. Successful transplantation of human acute myeloid leukemia (AML) cells into immunocompromised mice for the purpose of expansion of the cells

Secondary Outcome Measures :
  1. Identification of the locations of the protein complexes
  2. Interactions of the SEC and DotCom complexes in human leukemia samples

Biospecimen Retention:   Samples With DNA
Bone Marrow


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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of acute myeloid leukemia.
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of acute myeloid leukemia (AML)
  • Cryopreserved mixed-lineage leukemia (MLL) ENL AML rearrangement cells, normal karyotype and non-MLL rearrangement AML cells, and non-leukemic bone marrow samples from the COG tissue bank

    • 3 specimens of each type

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290107


Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Eric Guest, MD Children's Mercy Hospital

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01290107     History of Changes
Other Study ID Numbers: AAML11B7
COG-AAML11B7 ( Other Identifier: Children's Oncology Group )
NCI-2011-02847 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AAML11B7 ( Other Identifier: Children's Oncology Group )
First Posted: February 4, 2011    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by Children's Oncology Group:
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
childhood acute myeloid leukemia/other myeloid malignancies

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