An Observational Study for Dacogen Long-Term Treatment in Patients With Myelodysplastic Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01400633
First received: July 14, 2011
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to investigate the overall response rate (ORR) and safety when treating patients with myelodysplastic syndrome with decitabine. Decitabine is to be administered as long as there is evidence of clinical benefit.


Condition Intervention Phase
Myelodysplastic Syndromes
Drug: decitabine injection
Phase 4

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • overall response rate [ Time Frame: every 28 days up to approximately 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change of transfusion requirements [ Time Frame: every 4 weeks up to approximately 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: every 3 months up to approximately 5 years ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: every 4 weeks up to approximately 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 156
Study Start Date: December 2010
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001
decitabine injection decitabine intravenous injection 20mg/m2 once a day for 5 consecutive days every 4 weeks
Drug: decitabine injection
decitabine intravenous injection 20mg/m2 once a day for 5 consecutive days every 4 weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Secondary or tertiary hospitals in South Korea

Criteria

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 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 or 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: NCT01400633

Locations
Korea, Republic of
Ansan, Korea, Republic of
Anyang, Korea, Republic of
Busan, Korea, Republic of
Cheonan, Korea, Republic of
Chungcheongbuk-Do, Korea, Republic of
Chungnam, Korea, Republic of
Daegu, Korea, Republic of
Daejeon, Korea, Republic of
Gyeonggi-Do, Korea, Republic of
Hwasun Gun, Korea, Republic of
Incheon, Korea, Republic of
Jinju-Si, Korea, Republic of
Kwanju, Korea, Republic of
Pusan, Korea, Republic of
Seoul, Korea, Republic of
Suwon, Korea, Republic of
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
  More Information

No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01400633     History of Changes
Other Study ID Numbers: CR017842, DACOGENMDS4013, Long-term treatment of Dacogen
Study First Received: July 14, 2011
Last Updated: June 16, 2014
Health Authority: Korea: Food and Drug Administration
Republic of 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
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 August 25, 2014