Differentiation Therapy With Decitabine in Treating Patients With Myelodysplastic Syndrome

NCT01165996 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-03-04

Study results available
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Summary

RATIONALE: Decitabine may help myelodysplastic cells become more like normal stem cells. PURPOSE: This clinical trial studies differentiation therapy with decitabine in treating patients with myelodysplastic syndrome.

Conditions

  • Chronic Myelomonocytic Leukemia
  • de Novo Myelodysplastic Syndromes
  • Myelodysplastic Syndromes
  • Refractory Anemia
  • Refractory Anemia With Excess Blasts
  • Refractory Anemia With Ringed Sideroblasts
  • Refractory Cytopenia With Multilineage Dysplasia
  • Thrombocytopenia

Interventions

OTHER

flow cytometry

Correlative studies

OTHER

DNA methylation analysis

Correlative studies

OTHER

cytogenetic analysis

Correlative studies

DRUG

decitabine

Given subcutaneously

GENETIC

microarray analysis

Correlative studies

GENETIC

gene expression analysis

Correlative studies

OTHER

pharmacological study

Correlative studies

GENETIC

polymorphism analysis

Correlative studies

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Yogen Saunthararajah · Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  • Brenda Cooper, MD · Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-12-31
Completion
2012-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01165996 on ClinicalTrials.gov