Clinical Relevance of DNMT and HDAC Gene SNP on the Response to Decitabine Therapy for Myelodysplastic Syndrome

NCT04515914 | Completed DMC

• 1 other identifier: 2009-04-012
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Recent investigations have demonstrated that DNMT gene polymorphisms can contribute to the inter-individual variants in DNMT expression. Accordingly, we hypothesized that the DNMT and HDAC genes SNPs could predict the outcomes of decitabine therapy for myelodysplastic syndrome. Prospective collection of DNA from peripheral blood will be performed in the patients with MDS before commencement of decitabine therapy. We will evaluate the efficacy decitabine therapy according to the DNMT or HDAC gene SNPs in terms of following parameters: 1) hematolotic response (HR) or improvement (HI), or requirement of decitabine dose to achieve HR or HI, 2) complete (CR) or partial response (PR), or requirement of decitabine dose to achieve CR or PR, and 3) time to relapse or progression of MDS. The objective of this study is 1) to determine genotypes from DNA samples from MDS patients receiving Decitabine therapy, 2) to determine the association of clinical outcomes (HR, HI, CR, PR or time to progression to leukemia) following decitabine therapy with DNMT or HDAC genotypes, and 3) to analyze the impact of cytogenetic risk on the response or leukemic evolution following decitabine therapy for MDS.

Conditions

Myelodysplastic Syndrome

Keywords

DNA methyltransferase gene; Histone deacetylase gene; Single nucleotide polymorphism; Decitabine; Myelodysplastic syndrome

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  18 months

Secondary Outcomes (1)

• Time to progression or hematologic improvement

  18 months

Study Arms (2)

Decitabine therapy

The patients are treated with decitabine at least 1 cycles

non-Decitabine therapy

The Patients are diagnosed as MDS and do not be treated with decitabine therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include the patients who signed the subject informed consent form among the patients with MDS who were chosen to be treated with decitabine, plus additional MDS patients as a historical control.

You may qualify if:

• Decitabine treatment group
• Male and female aged 18 years or older.
• The patients diagnosed with (primary or secondary) MDS
• Patients with an IPSS score of ≥ Int-1
• Patients treated with Decitabine at least 1 cycles.
• Signed and dated informed consent before the start of genetic study using genomic DNA derived from blood sample.
• Historical control group
• Male and female aged 18 years or older.
• The patients diagnosed with (primary or secondary) MDS

You may not qualify if:

• Patients diagnosed with acute myelogenous leukemia (AML, bone marrow stem cell counts exceeding 20%) or other progressive malignant diseases.
• Diagnosis of chronic myelomonocytic leukemia (CMML) or MDS/MPD excluded.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples from MDS patients receiving Decitabine therapy

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Dong Hwan Kim, M.D.,Ph.D.

  Division of Hematology and Oncology/Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: August 17, 2020
• Study Start: September 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: August 17, 2020

Record last verified: 2011-01

Locations

KR (1)