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

Immune Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568333
• Other study ID #: ITP-Low-dose Decitabine
• Secondary ID: 81270578
• Status: Completed
• Phase: Phase 2
• Start date: August 2015
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

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

Locations

Country	Name	City	State
China	Shandong University Qilu hospital	Jinan	Shandong

Sponsors (3)

Lead Sponsor	Collaborator
Shandong University	Qingdao University, Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet count	plate level at the third month after the first dose of decitabine	the third month after the first dose of decitabine
Secondary	Bleeding score	the assessment of bleeding scores at enrollment and at the third month after the first dose of decitabine	at enrollment and the third month after the first dose of decitabine