Know Cancer

forgot password

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

Phase 4
20 Years
Open (Enrolling)
Myelodysplastic Syndromes

Thank you

Trial Information

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

This study is a prospective (the study follows a group of individuals over time), open label
(all people involved know the identity of the intervention), multicenter, single arm (one
group of patients receiving the same treatment), observational study to observe the response
rate and safety of decitabine when treating patients with myelodysplastic syndrome with
decitabine. Decitabine is to be administered as long as there is evidence of clinical
benefit. It will be assessed if the treatment duration could be prolonged by appropriate
toxicity management such as an active antibiotic prophylaxis or dose and schedule
modification, and whether this leads to potentially increased clinical benefits such as
higher response rate, longer time to Acute Myeloid Leukemia, and prolonged overall survival.
For safety evaluation, adverse events and peripheral blood findings will be collected. The
patient will receive decitabine intravenous injection 20mg/m2 once a day for 5 consecutive
days every 4 weeks.

Inclusion Criteria:

- Patients diagnosed with (primary or secondary) Myelodysplastic Syndrome including
Chronic Myelomonocytic Leukemia (CMML)

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

- Patients who were 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 therapy

- 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 or breast-feeding.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

overall response rate

Outcome Time Frame:

every 28 days up to approximately 5 years

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 2010

Completion Date:

December 2015

Related Keywords:

  • Myelodysplastic Syndromes
  • Myelodysplastic Syndrome
  • Dacogen
  • decitabine
  • epigenetic therapy
  • hypomethylating agent
  • Myelodysplastic Syndromes
  • Preleukemia