This study aimed to explore the efficacy and safety of romiplostim N01 in the treatment of relapsed/refractory chemoradiotherapy-induced aplastic anemia
Currently, there are few studies on the use of TPO-RAs after tumor radiotherapy and chemotherapy. Our center has published a study on the efficacy and safety of avatrombopag (AVA) in AA secondary to radiotherapy and chemotherapy. The study demonstrated that the ORR at 1, 3, and 6 months were 32.4%, 55.9%, and 58.8%, respectively. In a phase II/III study for refractory AA, romiplostim monotherapy achieved an ORR of 84% at week 27, which showed that romiplostim seemed to be effective and safe in patients with refractory aplastic anemia, with a recommended starting dose of 20 μg/kg once a week.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Romiplostim N01 20 µg/kg subcutaneously once a week for at least 3 months
ORR
Overall response rate (ORR) = PRR+CRR
Time frame: 3-month, 6-month
CRR
Complete response rate
Time frame: 3-month, 6-month, 12-month
AE rate
Proportion of patients with adverse events, according to CTCAE
Time frame: through study completion, an average of 1 year
Predictive factors of efficacy
Predictive factors of ORR or CRR
Time frame: 3-month
Clonal evolution rate
Proportion of patients progressed to MDS/ AML
Time frame: through study completion, an average of 1 year
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