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

Phase 2

Completed

• Conditions: Immune Thrombocytopenia
• Interventions: Drug: Decitabine

• Registration Number: NCT01568333
• Lead Sponsor: Shandong University

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 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.

Study Timeline

• Study First Submitted: 2012-03-29
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-02
• Study Start: 2015-08
• Primary Completion: 2017-10
• Status Verified: 2018-08
• Study Completion: 2018-08
• Last Update Submitted: 2018-08-17
• Last Update Posted: 2018-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Platelet count	the third month after the first dose of decitabine	plate level at the third month after the first dose of decitabine

Secondary Outcome Measures

Name	Time	Method
Bleeding score	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

Trial Locations

Locations (1)

Shandong University Qilu hospital; 🇨🇳 Jinan, Shandong, China