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| ID | Type | Description | Link |
|---|---|---|---|
| 81270578 | Other Grant/Funding Number | Natural Science Foundation of China |
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| Name | Class |
|---|---|
| Qingdao University | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decitabine | Experimental | Decitabine 3.5mg/m2,ivdrip,qd x 3d, every four weeks for one cycle. It will be given three cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decitabine | Drug | Decitabine 3.5mg/m2,ivdrip,qd x 3d, every four weeks for one cycle. It will be given three cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Platelet count | plate level at the third month after the first dose of decitabine | the third month after the first dose of decitabine |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ming Hou | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong University Qilu hospital | Jinan | Shandong | 250012 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15203276 | Background | van den Bosch J, Lubbert 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. doi: 10.1016/j.leukres.2003.11.016. | |
| 21713321 | Background | 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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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D000077209 | Decitabine |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
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| 31591739 | Derived | Zhou H, Qin P, Liu Q, Yuan C, Hao Y, Zhang H, Wang Z, Ran X, Chu X, Yu W, Wang X, Hou Y, Peng J, Hou M. A prospective, multicenter study of low dose decitabine in adult patients with refractory immune thrombocytopenia. Am J Hematol. 2019 Dec;94(12):1374-1381. doi: 10.1002/ajh.25646. Epub 2019 Oct 17. |
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D011741 |
| Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |