Study of Bone Marrow Samples From Patients With Acute Leukemia

Leukemia Clinical Trial

Official title:

Identifying the Genetic Basis of Adult AMKL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897559
• Other study ID #: CDR0000600323
• Secondary ID: ECOG-E1900T3
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: May 16, 2017
• Start date: July 3, 2008
• Est. completion date: November 11, 2009

Study information

• Verified date: May 2017
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 11, 2009
• Est. primary completion date: November 11, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia

Intervention

Genetic:
• gene expression analysis

• mutation analysis

• polymorphism analysis

• protein analysis

Other:
• flow cytometry

• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of gene mutations with adult acute megakaryoblastic leukemia (AMKL)		1 year