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NCT01290107 Clinical Trial

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

Leukemia Clinical Trial

Official title:
MLL Rearrangements in Acute Myeloid Leukemia: A Pilot Project to Expand and Study MLL-ENL in NOD SCID Gamma Mice

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01290107
Other study ID # AAML11B7
Secondary ID COG-AAML11B7NCI-
Status Completed
Phase N/A
First received February 3, 2011
Last updated May 17, 2016
Start date February 2011
Est. completion date May 2016

Study information
Verified date May 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date May 2016
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group N/A to 30 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Genetic:
• DNA analysis

• gene rearrangement analysis

• microarray analysis

• polymerase chain reaction

Other:
• immunological diagnostic method

• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Successful transplantation of human acute myeloid leukemia (AML) cells into immunocompromised mice for the purpose of expansion of the cells No
Secondary Identification of the locations of the protein complexes No
Secondary Interactions of the SEC and DotCom complexes in human leukemia samples No
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