Immune Thrombocytopenia
Conditions
Keywords
Decitabine, Immune thrombocytopenia
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.
Interventions
DRUGDecitabine
Decitabine 3.5mg/m2，ivdrip，qd x 3d, every four weeks for one cycle. It will be given three cycles.
Sponsors
Qingdao University
Shandong Provincial Hospital
Shandong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet count | the third month after the first dose of decitabine | plate level at the third month after the first dose of decitabine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed