Study of Bone Marrow Samples From Patients With Acute Leukemia

NCT ID: NCT00897559

Last Updated: 2017-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-03

Study Completion Date

2009-11-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

gene expression analysis

Intervention Type GENETIC

mutation analysis

Intervention Type GENETIC

polymorphism analysis

Intervention Type GENETIC

protein analysis

Intervention Type GENETIC

flow cytometry

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John Crispino, PhD

Role: STUDY_CHAIR

Robert H. Lurie Cancer Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ECOG-E1900T3

Identifier Type: -

Identifier Source: secondary_id

CDR0000600323

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.