This study aimed to explore the efficacy and safety of romiplostim N01 in the treatment of chemoradiotherapy-induced aplastic anemia (AA)
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 (Partial Response Rate)+CRR (Complete Response Rate)
Time frame: 3-month, 6-month
CRR
Proportion of patients who achieved CR
Time frame: 3-month, 6-month
Adverse event (AE) rate
Proportion of patients with AEs, according to CTCAE
Time frame: through study completion, an average of 1 year
Predictive factors for ORR or CRR
Calculated by single-/multivariate regression
Time frame: 3-month
Clonal evolution rate
Proportion of patients progressed to myelodysplastic syndromes (MDS)/ acute myeloid leukemia (AML)
Time frame: through study completion, an average of 1 year
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