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Efficacy and Safety of Dacogen

This study has been completed.
Sponsor:
Information provided by:
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01041846
First received: December 17, 2009
Last updated: January 27, 2011
Last verified: January 2011
History of Changes
  Purpose

The objective of this study is to evaluate the efficacy and safety data of the patients treated with decitabine (Dacogen) intravenous injection


Condition Intervention
Myelodysplastic Syndrome
 Drug: decitabine

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective Multicenter Observational Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome

Resource links provided by NLM:

Drug Information available for: Decitabine
U.S. FDA Resources

Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • 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 [ Time Frame: After 4 cycles and end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse event [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Cytogenetic response [ Time Frame: After 4 cycle ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: End of treatment ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: December 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001
decitabine injection into a vein 20 mg/m2 once daily for 5 days every 4 weeks
 Drug: decitabine
injection into a vein 20 mg/m2 once daily for 5 days every 4 weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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 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 (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 of breast-feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041846

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

No publications provided by Janssen Korea, Ltd., Korea

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medical Director, Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01041846     History of Changes
Other Study ID Numbers: CR015895
Study First Received: December 17, 2009
Last Updated: January 27, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Dacogen
Decitabine
Epigenetic therapy
Hypomethylating agent

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Decitabine
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013