Romiplostim in Combination With CsA vs. CsA in the Treatment of Newly Diagnosed NSAA (NCT06009497) | Clinical Trial Compass
UnknownPhase 4
Romiplostim in Combination With CsA vs. CsA in the Treatment of Newly Diagnosed NSAA
China44 participantsStarted 2023-08
Plain-language summary
Aplastic anemia (AA) is a group of clinical syndromes caused by a significant decrease in bone marrow hematopoietic tissue from different etiologies, resulting in hematopoietic failure. Treatment options for patients with aplastic anemia are very limited. In a phase II/III, multicenter, open-label study exploring the efficacy and safety of romiplostim, the primary endpoint showed an overall response rate of 84% \[95% CI 66-95%\] at week 27. However, there are no prospective clinical data exploring whether romiplostim combined with ciclosporin (CsA) can further improve efficacy than ciclosporin monotherapy in newly diagnosed NSAA. Therefore, we aimed to compare the efficacy and safety of romiplostim in combination with CsA versus CsA monotherapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years old.
✓. Clearly diagnosed as untreated NSAA.
✓. At least one of the following conditions was met at the time of enrollment: hemoglobin \<90 g/L. Platelet \<30×109/L, neutrophils \<1.0×109/L.
✓. Baseline liver and kidney function (ALT, AST, Cr) was less than 2 times the normal value.
✓. No active infection; Not pregnant or breastfeeding.
✓. Agree to sign the consent form.
✓. The Eastern Cancer Collaboration Group (ECOG) score was 0-2.
Exclusion criteria
✕. Pancytopenia caused by other causes, such as myelodysplastic syndrome (MDS).
✕. There is cytogenetic evidence of clonal hematologic bone marrow diseases (MDS, AML).