Clinical Trial: A Multi-center Study of Low-dose Decitabine for the Treatment of Immune Thrombocytopenia
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Multi-center Study of Low-dose Decitabine for the Treatment of Immune Thrombocytopenia
Brief Summary: Decitabine has been reported to have a clinically significant, often long lasting effect on the platelet count in myelodysplastic syndromes(MDS). It is also reported that decitabine could increase platelet counts by enhancing megakaryocyte maturation and platelet release. Immune thrombocytopenia(ITP) is known as an immune-mediated acquired disease characterized by transient or persistent decrease of the platelet count. However, refractory ITP is lacking of effective treatments and the efficacy of decitabine in ITP remains poorly understood. Data from this study may provide some idea of decitabine in the treatment of ITP.
Detailed Summary: The investigators are undertaking a multicenter, single-arm study of 30 primary ITP adult patients from 5 medical centers in China. All the participants are selected to receive low-dose of decitabine treatment (given intravenously at a dose of 3.5mg/m2 for 3 days). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
Sponsor: Shandong University
Current Primary Outcome:
- Platelet count [ Time Frame: every 3 days after the treatment ]
- Megakaryocyte Polyploidy [ Time Frame: 8 days after every treatment cycle ]
Original Primary Outcome: Platelet count [ Time Frame: every 3 days after the treatment ]
Current Secondary Outcome: Bleeding score [ Time Frame: every 3 days after the treatment ]
Original Secondary Outcome: Same as current
Information By: Shandong University
Dates:
Date Received: March 29, 2012
Date Started: June 2015
Date Completion: December 2017
Last Updated: July 26, 2016
Last Verified: March 2016
