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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
rhTPO 1.0 μg/kg·d subcutaneously for 7\~14 consecutive days
Qilu hospital, Shandong University
Jinan, Shandong, China
RECRUITINGEvaluation 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.
Time frame: 21 days since the first administration
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