A Multi-center Study of Low-dose Decitabine for the Treatment of Immune Thrombocytopenia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Decitabine Decitabine 3.5mg/m2，ivdrip，qd x 3d, every four weeks for one cycle. It will be given three cycles. |
Drug: Decitabine
Decitabine 3.5mg/m2，ivdrip，qd x 3d, every four weeks for one cycle. It will be given three cycles.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
adult patients with the diagnosis of ITP according to the International Working Group (IWG) guidelines
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failure to splenectomy or at least four standard ITP-specific treatments, but not necessarily undergone splenectomye
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baseline peripheral platelet count less than 30,000/uL or the presence of bleeding symptoms
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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:
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secondary ITP
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pregnancy
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hypertension
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cardiovascular disease
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diabetes
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liver and kidney function impairment
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HCV, HIV, HBsAg seropositive status
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patients with systemic lupus erythematosus and/or antiphospholipid syndrome
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shandong University Qilu hospital | Jinan | Shandong | China | 250012 |
Sponsors and Collaborators
- Shandong University
- Qingdao University
- Shandong Provincial Hospital
Investigators
- Principal Investigator: Ming Hou, Qilu hospital, Shandong University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- ITP-Low-dose Decitabine
- 81270578