Myeloid Leukemia Clinical Trial
Official title:
Genome-wide Pharmacogenetic Candidate Gene SNP Array-based Approach to Predict Chemoresponse and Survival in Patients With Acute Myeloid Leukemia With Normal Karyotype
The most reliable prognostic marker of acute myeloid leukemia(AML) is cytogenetics by
karyotyping. According to cytogenetic results, the patients with AML are classified as
better, intermediate and poor prognosis groups. The normal karyotype AML was reported in
about 50% of all AML and classified as intermediate risk group. However, the patients with
normal karyotype AML showed various prognosis. Therefore, the further studies about subgroup
analysis of normal karyotype AML are needed. Recently, the understandings of human genome
polypmorphism using SNP array have been accumulated. However, the advanced researches for
clinical application are not enough.
The study design is a retrospective and single-center study. The patients with normal
karyotyping AML who were diagnosed from 1994 to 2008 at Samsung Medical Center (South Korea)
will be enrolled. The stored bone marrow samples of enrolled patients are used for genome
wide scanning by SNP array.
The purpose of present study is to develop predictive pharmacogenemic biomarkers model
associated wit clinical outcomes including efficacy and toxicity in patients with AML with
normal karyotype treated with chemotherapy using pharmacogenetic SNP array. And secondly, to
develop enrichment clinical trial based on predictive pharmacogenomic model.
| Status | Recruiting |
| Enrollment | 500 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - patients with normal karyotype 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 definitive criteria |
Observational Model: Case-Only, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Samsung Medical Center | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Samsung Medical Center |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | overall response rate | within 1 month after enrollment | No | |
| Secondary | overall survival time | within 1 month after enrollment | No |
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