Immune Thrombocytopenia | A Multi-center Study of Low-dose Decitabine for the Treatment of Immune Thrombocytopenia
Immune Thrombocytopenia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - adult patients with the diagnosis of ITP according to the International Working Group (IWG) guidelines - failure to splenectomy or at least four standard ITP-specific treatments, but not necessarily undergone splenectomye - baseline peripheral platelet count less than 30,000/uL or the presence of bleeding symptoms - need of treatment(s) (including, but not limited to, low dose of corticosteroids) to minimize the risk of clinically significant bleeding. Need of on-demand or Exclusion Criteria: - secondary ITP - pregnancy - hypertension - cardiovascular disease - diabetes - liver and kidney function impairment - HCV, HIV, HBsAg seropositive status - patients with systemic lupus erythematosus and/or antiphospholipid syndrome
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:DecitabineDecitabine 3.5mg/m2，ivdrip，qd x 3d, every four weeks for one cycle. It will be given three cycles.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
DecitabineDecitabine 3.5mg/m2，ivdrip，qd x 3d, every four weeks for one cycle. It will be given three cycles.
Start Date: August 2015
Completed Date: August 2018
Phase: Phase 2
Primary Outcome: Platelet count
Secondary Outcome: Bleeding score
Study sponsors, principal investigator, and references
Principal Investigator: Ming Hou
Lead Sponsor: Shandong University
Collaborator: Qingdao University
van den Bosch J, Lübbert M, Verhoef G, Wijermans PW. The effects of 5-aza-2'-deoxycytidine (Decitabine) on the platelet count in patients with intermediate and high-risk myelodysplastic syndromes. Leuk Res. 2004 Aug;28(8):785-90.