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A Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01041846
First received: December 17, 2009
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Myelodysplastic Syndrome
Drug: No intervention
Phase 4

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:


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

Primary Outcome Measures:
  • Number of patients with complete remission [ Time Frame: Up to 61 days ] [ Designated as safety issue: No ]
    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.

  • Number of patients with partial remission [ Time Frame: Up to 61 days ] [ Designated as safety issue: No ]
    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)

  • Number of patients with hematological improvement [ Time Frame: Up to 61 days ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: After 4 cycles and end of treatment ] [ Designated as safety issue: No ]
    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:
  • Cytogenetic response rate [ Time Frame: Up to 61 days ] [ Designated as safety issue: No ]
  • Overall survival rate [ Time Frame: Up to 61 days ] [ Designated as safety issue: No ]
    Overall survival will be evaluated from the registration day to death.

  • Time to acute myeloid leukemia evolution [ Time Frame: Up to 61 days ] [ Designated as safety issue: No ]
    The time of progression from myelodysplastic syndromes to acute myeloid leukemia.

  • Number of patients with progression-free survival status [ Time Frame: Up to 61 days ] [ Designated as safety issue: No ]
    Hospitalization or undergoes surgical procedure due to disease progression.

  • Number of patients with adverse event [ Time Frame: Up to 61 days ] [ Designated as safety issue: Yes ]

Enrollment: 103
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
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.

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.

  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:

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041846

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

Additional Information:
No publications provided by Janssen Korea, Ltd., Korea

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01041846     History of Changes
Other Study ID Numbers: CR015895, DECKOR5002
Study First Received: December 17, 2009
Last Updated: July 26, 2013
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014