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Efficacy and Safety of Dacogen

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

Summary

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

Description

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

Conditions

Myelodysplastic Syndrome

Intervention

decitabine

Status

Active, not recruiting

Source

Janssen Korea, Ltd., Korea

Results (where available)

View Results

Links

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

Clinical Trials [1236 Associated Clinical Trials listed on BioPortfolio]

Escalation Study to Determine Bioavailability of a Single Oral Dose of Decitabine in Patients With Myelodysplastic Syndrome (MDS)

The purpose of this study is to determine how the body absorbs decitabine when taken orally in patients with Myelodysplastic Syndrome (MDS). Safety will also be assessed for this oral dose...

Decitabine and Clofarabine in Higher Risk Myelodysplastic Syndromes (MDS)

The goal of this clinical research study is to learn if sequential administration of decitabine and clofarabine can help to control myelodysplastic syndrome (MDS) better than decitabine al...

Study of Decitabine Treatment for Taiwanese Myelodysplastic Syndrome Patients

The purpose of the study is to evaluate the response rate of decitabine at a dose regimen of 20mg/m2 administered by 1 hour infusion for first consecutive 5 days of every 28-day cycle, to ...

Decitabine and Arsenic Trioxide for Myelodysplastic Syndrome(MDS)

This is a prospective,controlled and multi-institution trial.The aim is to identify if using decitabine and Arsenic Trioxide(ATO) as the therapy of Myelodysplastic Syndrome(MDS) has better...

A Study of Decitabine Given to Adults With Advanced-Stage Myelodysplastic Syndromes

The purpose of this study is to determine the overall response rate in patients with myelodysplastic syndromes (MDS) given a daily dosing schedule of decitabine.

PubMed Articles [4746 Associated PubMed Articles listed on BioPortfolio]

Successful treatment of high-risk myelodysplastic syndrome with decitabine-based chemotherapy followed by haploidentical lymphocyte infusion: A case report and literature review.

The current therapy for elderly patients with high-risk myelodysplastic syndromes (MDSs) remains unsatisfactory. Decitabine, which has been approved to treat MDS, cannot eliminate malignant clones of ...

Clonal cytogenetic abnormalities of undetermined significance.

Myelodysplastic syndromes are a group of hematopoietic stem cell diseases characterized by cytopenia(s), morphological dysplasia, and clonal hematopoiesis. In some patients, the cause of cytopenia(s) ...

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...

Remission of relapsing polychondritis after successful treatment of myelodysplastic syndrome with azacitidine: a case and review of the literature.

Relapsing polychondritis (RP) is a rare autoimmune disorder, and myelodysplastic syndrome (MDS) is accompanied by RP at variable rates. Herein, we report a case with RP and MDS who responded dramatica...

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.

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.

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.

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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