A Multi-center Study of Low-dose Decitabine for the Treatment of Immune Thrombocytopenia

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2017

Detailed Description

The investigators are undertaking a multicenter, single-arm study of primary ITP adult patients from 9 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 per cycle for 3 cycles). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Interventions

  • Drug: Decitabine
    • Decitabine 3.5mg/m2,ivdrip,qd x 3d, every four weeks for one cycle. It will be given three cycles.

Arms, Groups and Cohorts

  • Experimental: Decitabine
    • Decitabine 3.5mg/m2,ivdrip,qd x 3d, every four weeks for one cycle. It will be given three cycles.

Clinical Trial Outcome Measures

Primary Measures

  • Platelet count
    • Time Frame: the third month after the first dose of decitabine
    • plate level at the third month after the first dose of decitabine

Secondary Measures

  • Bleeding score
    • Time Frame: at enrollment and the third month after the first dose of decitabine
    • the assessment of bleeding scores at enrollment and at the third month after the first dose of decitabine

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shandong University
  • Collaborator
    • Qingdao University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ming Hou, Professor and Director – Shandong University
  • Overall Official(s)
    • Ming Hou, Principal Investigator, Qilu hospital, Shandong University

References

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.

Wang J, Yi Z, Wang S, Li Z. The effect of decitabine on megakaryocyte maturation and platelet release. Thromb Haemost. 2011 Aug;106(2):337-43. doi: 10.1160/TH10-11-0744. Epub 2011 Jun 28.

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