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Chemotherapy-related myelosuppression usually occurs in AML patients, which induces severe thrombocytopenia and haemorrhage, a leading cause of death. This clinical trial aims at evaluating efficacy and safety of rhTPO in management of chemotherapy-induced thrombocytopenia in acute myelocytic leukemia.
The investigators are undertaking a parallel group, multicentre, randomized controlled trial of 80 adults with chemotherapy-induced thrombocytopenia from 8 medical centers in China. AML patients with PLT count <30×10^9/L during the previous cycle of chemotherapy are randomized into two groups that one receives rhTPO at 1.0μg/kg·d subcutaneously for 7~14 consecutive days and the other receives no rhTPO or other thrombopoietic factor. 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 |
|---|---|---|---|
| rhTPO | Experimental | rhTPO 1.0 μg/kg·d subcutaneously for 7~14 consecutive days |
|
| control | No Intervention | no thrombopoietic agents |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhTPO | Drug | rhTPO 1.0 μg/kg·d subcutaneously for 7~14 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of platelet response | days that PLT count rebound to 30×10^9/L, 50×10^9/L and 100×10^9/L, respectively, from the minimal level after the very cycle of chemotherapy. | 21 days since the first administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Hou | Contact | houming@medmail.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu hospital, Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |