Efficacy and Safety of Dacogen

2014-07-23 21:11:14 | BioPortfolio


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


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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Myelodysplastic Syndrome




Active, not recruiting


Janssen Korea, Ltd., Korea

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:11:14-0400

Clinical Trials [1335 Associated Clinical Trials listed on BioPortfolio]

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PubMed Articles [4693 Associated PubMed Articles listed on BioPortfolio]

Mutation Clearance after Transplantation for Myelodysplastic Syndrome.

Allogeneic hematopoietic stem-cell transplantation is the only curative treatment for patients with myelodysplastic syndrome (MDS). The molecular predictors of disease progression after transplantatio...

Decitabine induces regulatory T cells, inhibits the production of IFN-gamma and IL-17 and exerts preventive and therapeutic efficacy in rodent experimental autoimmune neuritis.

Guillain-Barré syndrome (GBS) is an immune-mediated acute disorder of the peripheral nervous system. Despite treatment, there is an associated mortality and severe disability in 9 to 17% of the cases...

Usefulness of tocilizumab for treating rheumatoid arthritis with myelodysplastic syndrome: A case report and literature review.

Dysregulated immune function in rheumatoid arthritis (RA) might lead to the development of myelodysplastic syndrome (MDS). Serum interleukin-6 (IL-6) concentrations are increased in both RA and MDS pa...

Gastric carcinoma subsequent to myelodysplastic syndrome with t (1; 19) chromosome translocation: A rare case report and its potential mechanisms.

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Risk of acute myeloid leukemia and myelodysplastic syndrome after autotransplants for lymphomas and plasma cell myeloma.

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Medical and Biotech [MESH] Definitions

Clonal myeloid disorders that possess both dysplastic and proliferative features but are not properly classified as either MYELODYSPLASTIC SYNDROMES or MYELOPROLIFERATIVE DISORDERS.

A myelodysplastic-myeloproliferative disease characterized by monocytosis, increased monocytes in the bone marrow, variable degrees of dysplasia, but an absence of immature granulocytes in the blood.

Condition with a variable constellation of phenotypes due to deletion polymorphisms at chromosome location 22q11. It encompasses several syndromes with overlapping abnormalities including the DIGEORGE SYNDROME, VELOCARDIOFACIAL SYNDROME, and CONOTRUNCAL AMOMALY FACE SYNDROME. In addition, variable developmental problems and schizoid features are also associated with this syndrome. (From BMC Med Genet. 2009 Feb 25;10:16) Not all deletions at 22q11 result in the 22q11deletion syndrome.

Rare congenital disorder with multiple anomalies including: characteristic dysmorphic craniofacial features, musculoskeletal abnormalities, neurocognitive delay, and high prevalence of cancer. Germline mutations in H-Ras protein can cause Costello syndrome. Costello syndrome shows early phenotypic overlap with other disorders that involve MAP KINASE SIGNALING SYSTEM (e.g., NOONAN SYNDROME and cardiofaciocutaneous syndrome).

An autosomal dominant aneurysm with multisystem abnormalities caused by increased TGF-BETA signaling due to mutations in type I or II of TGF-BETA RECEPTOR. Additional craniofacial features include CLEFT PALATE; CRANIOSYNOSTOSIS; HYPERTELORISM; or bifid uvula. Phenotypes closely resemble MARFAN SYNDROME; Marfanoid craniosynostosis syndrome (Shprintzen-Goldberg syndrome); and EHLERS-DANLOS SYNDROME.

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