Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of Bone Marrow Samples From Patients With Acute Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: May 9, 2009
Last updated: NA
Last verified: September 2008
History: No changes posted

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

Study Type: Observational
Official Title: Identifying the Genetic Basis of Adult AMKL

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Correlation of gene mutations with adult acute megakaryoblastic leukemia (AMKL) [ Designated as safety issue: No ]
  • Ability of Src kinase inhibitors (SU6656, dasatinib) to induce differentiation of AMKL blasts [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2008
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


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


  • Not specified


  • Not specified
  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 identifier: NCT00897559

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Study Chair: John Crispino, PhD Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided Identifier: NCT00897559     History of Changes
Other Study ID Numbers: CDR0000600323, ECOG-E1900T3
Study First Received: May 9, 2009
Last Updated: May 9, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adult acute megakaryoblastic leukemia (M7) processed this record on March 03, 2015