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| ID | Type | Description | Link |
|---|---|---|---|
| DECKOR5002 | Other Identifier | Janssen Korea, Ltd., Korea |
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The purpose of this study is to evaluate the effectiveness and safety of decitabine (Dacogen) intravenous injection in patients with Myelodysplastic Syndrome.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decitabine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with complete remission | 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. | Up to 61 days |
| Number of patients with partial remission | 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) | Up to 61 days |
| Number of patients with hematological improvement | Up to 61 days | |
| Response rate | 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. | After 4 cycles and end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Cytogenetic response rate | Up to 61 days | |
| Overall survival rate | Overall survival will be evaluated from the registration day to death. | Up to 61 days |
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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
Exclusion Criteria:
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The patients who signed the subject informed consent form among the patients with myelodysplastic syndrome who were treated with decitabine
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31375393 | Derived | Jung KS, Kim YJ, Kim YK, Park SK, Kim HG, Kim SJ, Park J, Choi CW, Do YR, Kim I, Park S, Mun YC, Jeong SH, Kim MK, Yi HG, Chang MH, Kim SY, Lee JH, Jang JH. Clinical Outcomes of Decitabine Treatment for Patients With Lower-Risk Myelodysplastic Syndrome on the Basis of the International Prognostic Scoring System. Clin Lymphoma Myeloma Leuk. 2019 Oct;19(10):656-664. doi: 10.1016/j.clml.2019.06.003. Epub 2019 Jun 27. | |
| 21659363 |
| Label | URL |
|---|---|
| A Prospective, Multicenter, Observational Study of Dacogen Treatment in Patients with Myelodysplastic Syndrome | View source |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Time to acute myeloid leukemia evolution | The time of progression from myelodysplastic syndromes to acute myeloid leukemia. | Up to 61 days |
| Number of patients with progression-free survival status | Hospitalization or undergoes surgical procedure due to disease progression. | Up to 61 days |
| Number of patients with adverse event | Up to 61 days |
| Derived |
| Lee JH, Jang JH, Park J, Park S, Joo YD, Kim YK, Kim HG, Choi CW, Kim SH, Park SK, Park E, Min YH. A prospective multicenter observational study of decitabine treatment in Korean patients with myelodysplastic syndrome. Haematologica. 2011 Oct;96(10):1441-7. doi: 10.3324/haematol.2011.046078. Epub 2011 Jun 9. |