A Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01041846
Recruitment Status : Completed
First Posted : January 1, 2010
Last Update Posted : July 29, 2013
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Brief Summary:
The purpose of this study is to evaluate the effectiveness and safety of decitabine (Dacogen) intravenous injection in patients with Myelodysplastic Syndrome.

Condition or disease Intervention/treatment
Myelodysplastic Syndrome Drug: No intervention

Detailed Description:
This is a prospective (in which the patients are first identified and then followed forward as time passes), multi-center (study conducted at multiple sites), observational study (a scientific study to make a clear and easy understanding of the cause and effect relationship) to evaluate the effectiveness and safety information of a 5 day decitabine (Dacogen) regimen in patients with Myelodysplastic Syndrome. This study consist of 3 phases; pre-treatment phase, treatment phase and end of treatment (Day 28~61 after last administration of Dacogen). The patients will receive decitabine intravenous injection 20 mg/m2 one hour once daily for 5 consecutive days for every 4 weeks. Safety evaluations including adverse events and clinical laboratory tests and will be evaluated with adverse events reported for the period ranging from informed consent and during the study to the end of treatment visit including 56 days (8 weeks) after the last administration of the clinical study treatment.

Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Multicenter Observational Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome
Study Start Date : December 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Decitabine

Group/Cohort Intervention/treatment
Decitabine Drug: No intervention
This is an observational study. Patients receiving 20 mg/m2 of decitabine injection intravenously (into a vein) once daily for 5 days every 4 weeks will be observed.

Primary Outcome Measures :
  1. Number of patients with complete remission [ Time Frame: Up to 61 days ]
    The complete response includes the evaluations of Bone marrow aspiration and biopsy (less than or equal to 5 percents myeloblast), persistent dysplasia and peripheral blood.

  2. Number of patients with partial remission [ Time Frame: Up to 61 days ]
    The partial response includes all complete remission evaluating parameters with the exception of bone marrow blasts are decreased by more than or equal to 50 percents over pretreatment but still more than 5 percents and cellularity (the state of a tissue or other mass as regards the number of its constituent cells) and morphology (examination of structure)

  3. Number of patients with hematological improvement [ Time Frame: Up to 61 days ]
  4. Response rate [ Time Frame: After 4 cycles and end of treatment ]
    Response rate is the combination of complete remission, partial remission and hematological improvement and performed 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.

Secondary Outcome Measures :
  1. Cytogenetic response rate [ Time Frame: Up to 61 days ]
  2. Overall survival rate [ Time Frame: Up to 61 days ]
    Overall survival will be evaluated from the registration day to death.

  3. Time to acute myeloid leukemia evolution [ Time Frame: Up to 61 days ]
    The time of progression from myelodysplastic syndromes to acute myeloid leukemia.

  4. Number of patients with progression-free survival status [ Time Frame: Up to 61 days ]
    Hospitalization or undergoes surgical procedure due to disease progression.

  5. Number of patients with adverse event [ Time Frame: Up to 61 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients who signed the subject informed consent form among the patients with myelodysplastic syndrome who were treated with decitabine

Inclusion Criteria:

Patients diagnosed with (primary or secondary) Myelodysplastic Syndrome including chronic myelomonocytic leukemia (CMML) with an International Prognostic Scoring System more than or equal to Interferon-1

  • Patients who have never treated with hypomethylating agent (azacitidine and decitabine)
  • 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 as defined in protocol, in case of male patients who will not have a baby within 2 months after the completion of decitabine therapy

Exclusion Criteria:

  • Patients diagnosed with acute myelogenous leukemia (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 and breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01041846

Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Janssen Korea, Ltd., Korea Identifier: NCT01041846     History of Changes
Other Study ID Numbers: CR015895
DECKOR5002 ( Other Identifier: Janssen Korea, Ltd., Korea )
First Posted: January 1, 2010    Key Record Dates
Last Update Posted: July 29, 2013
Last Verified: July 2013

Keywords provided by Janssen Korea, Ltd., Korea:
Myelodysplastic Syndrome
Epigenetic therapy
Hypomethylating agent

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors