Efficacy and Safety of Dacogen
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)
Links
- Source: http://clinicaltrials.gov/show/NCT01041846
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Myelodysplastic-myeloproliferative Diseases
Clonal myeloid disorders that possess both dysplastic and proliferative features but are not properly classified as either MYELODYSPLASTIC SYNDROMES or MYELOPROLIFERATIVE DISORDERS.
22q11 Deletion Syndrome
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.
Leukemia, Myelomonocytic, Chronic
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.
Costello 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).
Loeys-dietz 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.
Clinical Trials
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...
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.
Low-Dose Decitabine in Myelodysplastic Syndrome Post Azacytidine Failure
To study if decitabine can help to control MDS in patients who have failed on therapy with azacytidine, the current standard of therapy.
PubMed Articles
Comparison of 7-day azacitidine and 5-day decitabine for treating myelodysplastic syndrome.
Two DNA methyltransferase inhibitors, azacitidine and decitabine, are currently approved for the treatment of myelodysplastic syndrome (MDS). Choosing between these drugs is an important practical iss...
We analyzed the role of antibiotic prophylaxis during decitabine treatment for MDS. The primary endpoint was the incidence of febrile episodes. The total number of decitabine cycles given to 28 patien...
Abstract Objective: Azacitidine and decitabine are used to treat patients with myelodysplastic syndromes (MDS) in the United States (US). This study sought to assess their relative cost-effective...
We conducted a clinical trial of low-dose decitabine plus aclacinomycin/cytarabine (AA) treatment (DAA) for 20 patients with refractory/relapsed de novo acute myeloid leukemia (AML) or AML transformed...
Role of human nucleoside transporters in the uptake and cytotoxicity of azacitidine and decitabine.
The nucleoside analogs 5-azacytidine (azacitidine) and 5-aza-2'-deoxycytidine (decitabine) are active against acute myeloid leukemia and myelodysplastic syndromes. Cellular transport across membranes...
