- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01066286
Genome Wide SNP Array-based Approach to Detect Micro-cytogenetic Lesions and KIT Mutation to Improve Treatment Outcomes in Patients With Core-binding Factor Positive Acute Myeloid Leukemia
Core binding factor (CBF) positive acute myeloid leukemia (AML) consist of 15% of patients in overall AML, expected to harbor a favorable prognosis. However, around a half of cases relapses. Accordingly, more sophisticated classification in CBF positive AMLs is essential to achieve further improvement in the treatment outcome. The current study is designed to evaluate CBF positive AML patients with genome-wide SNP array and KIT mutation study in CBF positive AML patients diagnosed at the Samsung Medical Center and Hwasun Chonnam National University Hospital, Korea between 1994 and 2008.
- Construction of the CBF positive AML patient cohort: clinical database establishment (including treatment outcomes and prognosis) and extraction/storage of tumor cell DNAs from marrow samples, then processing of Affymetrix SNP array 6.0.
- Construction of prognostic predictive model using pharmacogenomics with the results of genotypes and copy number variations (CNVs).
- Detection of hidden microscopic cytogenetic lesions with SNP array technique, and correlation with clinical outcomes in CBF positive AML.
- Detection of KIT, FLT3/ITD, and NPM1 gene mutation and its correlation with clinical outcomes in CBF positive AML.
The current study attempts to analyze genetic data of core binding factor (CBF) positive acute myeloid leukemia (AML) using genome wide SNP array technique with tumor DNAs collected at the time of diagnosis.
- To detect microcytogenetic lesions and will analyze its prognostic significance
- To analyze genome-wide genotypes and copy number variations (CNVs) using pharmacogenetic approach and will construct a prognostic predictive model
- To detect KIT, FLT3/ITD and NPM1 mutation and evaluate its prognostic significance. The present study will establish individualized therapy for CBF positive AML, will provide a basis for molecular marker guided clinical trial in CBF positive AML.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Dong Hwan Kim, M.D.,Ph.D.
- Phone Number: +82-2-3410-1768
- Email: dr.dennis.kim@samsung.com
Study Locations
-
-
-
Seoul, Korea, Republic of, 135-710
- Recruiting
- Samsung Medical Center
-
Contact:
- Dong Hwan Kim, M.D., Ph. D.
- Phone Number: +82-2-3410-1768
- Email: dr.dennis.kim@samsung.com
-
Principal Investigator:
- Dong Hwan Kim, M.D.,Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients with core binding factor positive acute myeloid leukemia
- 18 years or older
- patients were treated with standard chemotherapy
- patients with available medical record and stored bone marrow specimen at time of diagnosis
Exclusion Criteria:
- no definive criteria
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
core binding factor positive
core binding factor positive acute myeloid leukemia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
response rate
Time Frame: within 1 month after enrollment
|
within 1 month after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival and progression-free survival
Time Frame: within 1 month after enrollment
|
within 1 month after enrollment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-10-069
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myeloid Leukemia
-
University of PennsylvaniaActive, not recruitingAcute Myeloid Leukemia, in Relapse | Acute Myeloid Leukemia, Refractory | Acute Myeloid Leukemia, PediatricUnited States
-
Betta Pharmaceuticals Co., Ltd.Not yet recruitingAcute Myeloid Leukemia LeukemiaChina
-
Washington University School of MedicineWithdrawnRefractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
C. Babis AndreadisGateway for Cancer Research; AVEO Pharmaceuticals, Inc.TerminatedAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
Peking University People's HospitalBeijing JD Biotech Co. LTD.RecruitingAcute Myeloid Leukemia, in Relapse | Acute Myeloid Leukemia RefractoryChina
-
Xuzhou Medical UniversityRecruitingAcute Myeloid Leukemia, in Relapse | Acute Myeloid Leukemia RefractoryChina
-
Bio-Path Holdings, Inc.RecruitingAcute Myeloid Leukemia, in Relapse | Acute Myeloid Leukemia RefractoryUnited States
-
Yale UniversityPfizerTerminatedACUTE MYELOID LEUKEMIAUnited States
-
Xuzhou Medical UniversityRecruitingAcute Myeloid Leukemia, in Relapse | Acute Myeloid Leukemia RefractoryChina
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Myeloid Leukemia/Other Myeloid MalignanciesUnited States