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A Prospective Multicenter Observational Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome

18 Years
Not Enrolling
Myelodysplastic Syndrome

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Trial Information

A Prospective Multicenter Observational Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome

The current trial is a prospective, multi-center, Phase 4, observational study that will
collect domestic data on the efficacy and safety of a five-day decitabine (Dacogen) regimen
in domestic patients with Myelodysplastic Syndrome (MDS). The results will be utilized as
basic data to establish the domestic guidelines for decitabine treatment. This study is
designed to observe the response rate and safety of decitabine in patients with MDS who were
treated with decitabine. All adverse events reported from the time a signed and dated
informed consent form is obtained until the last visit will be evaluated. Observational
Study - No investigational drug administered. The patient will receive decitabine
intravenous injection 20mg/m2 once a day for 5 consecutive days for every 4 weeks.

Inclusion Criteria:

- The patients diagnosed with (primary or secondary) Myelodysplastic Syndrome including
chronic myelomonocytic leukemia (CMML)

- Patients with an International Prognostic Scoring System >= Int-1

- Patients who have never treated with hypomethylating agent(azacitidine and

- Female patients who are postmenopausal or received contraceptive operation or refrain
from sexual relations. Women of childbearing potential should conduct an effective
method of birth control (oral contraceptives, injections, intrauterine device, double
barrier method, contraceptive patch and male partner's sterilization),in case of male
patients who will not have a baby within 2 months after the completion of decitabine

- Patients who signed an informed consent document indicating that they understand the
purpose of and procedures required for the study and are willing to participate in
the study

Exclusion Criteria:

- Patients diagnosed with acute myelogenous leukemia (AML, bone marrow stem cell counts
exceeding 20 %) or other progressive malignant diseases

- Patients with active infection of virus or bacteria

- Patients who used to be treated with azacitidine or decitabine

- Patients who are hypersensitive to excipients of decitabine

- Patients who are pregnant of breast-feeding

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Overall response rate according to the response criteria of 'International Working Group 2006' which is standardized criteria for assessing response are essential to ensure comparability among clinical trials for patients with MDS

Outcome Time Frame:

After 4 cycles and end of treatment

Safety Issue:


Principal Investigator

Janssen Korea, Ltd. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Korea, Ltd.


Korea: Food and Drug Administration

Study ID:




Start Date:

December 2008

Completion Date:

July 2010

Related Keywords:

  • Myelodysplastic Syndrome
  • Dacogen
  • Decitabine
  • Epigenetic therapy
  • Hypomethylating agent
  • Myelodysplastic Syndromes
  • Preleukemia