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Study of Bone Marrow Samples From Patients With Acute Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00897559
First Posted: May 12, 2009
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
  Purpose

RATIONALE: Studying the genes expressed in samples of bone marrow from patients with cancer may help doctors identify biomarkers related to cancer.

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


Condition Intervention
Leukemia Genetic: gene expression analysis Genetic: mutation analysis Genetic: polymorphism analysis Genetic: protein analysis Other: flow cytometry Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Identifying the Genetic Basis of Adult AMKL

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Correlation of gene mutations with adult acute megakaryoblastic leukemia (AMKL) [ Time Frame: 1 year ]

Enrollment: 40
Study Start Date: July 3, 2008
Study Completion Date: November 11, 2009
Primary Completion Date: November 11, 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To perform high throughput sequencing of a set of megakaryocyte specific transcription factors, tyrosine kinases, and Src kinases in DNA isolated from bone marrow specimens of adults with acute megakaryoblastic leukemia (AMKL).
  • To assay the ability of Src kinase inhibitors (SU6656, dasatinib) to induce differentiation of AMKL blasts in these patients.

OUTLINE: DNA from previously collected bone marrow samples are sequenced to analyze genes associated with transcription factors (GATA1, GATA2, SCL, FOG-1, ETS1, ETS2, ERG, FLI-1, GABP, HOXA11, NF-E2, and RUNX1), tyrosine kinases (JAK2, JAK3, and c-MPL), and Src family kinases (LYN, FYN, and HCK) and compared with control DNA. Using bioinformatics, gene alterations are compared to known polymorphisms and subsequent changes in the amino acid sequence of the encoded protein. Subsequent assays assess the effect on proliferation and differentiation and in vitro studies evaluate the consequences of mutations on transcription factor and kinase activity abilities. The effect of SU6656 and dasatinib on cell death and polyploidization is evaluated by flow cytometry and compared with control DNA.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Acute Leukemia
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of adult acute megakaryoblastic leukemia
  • Archived bone marrow specimens from the ECOG tissue repository

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
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): NCT00897559


Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: John Crispino, PhD Robert H. Lurie Cancer Center
  More Information

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00897559     History of Changes
Other Study ID Numbers: CDR0000600323
ECOG-E1900T3
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: May 17, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data sharing is dictated by the group's data sharing plan.

Keywords provided by Eastern Cooperative Oncology Group:
adult acute megakaryoblastic leukemia (M7)

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms