An Observational Study for Dacogen Long-Term Treatment in Patients With Myelodysplastic Syndrome
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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 |
- overall response rate [ Time Frame: every 28 days up to approximately 5 years ] [ Designated as safety issue: No ]
- 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: | 145 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (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 |
Secondary or tertiary hospitals in South Korea
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| 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 | |
| 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: | May 10, 2013 |
| 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 May 23, 2013