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Retrospective studies have shown that Solafinib maintenance therapy may reduce recurrence after transplantation of heterogenetic hematopoietic stem cells in patients with acute myeloid leukemia with FLT3-ITD.
led a team led by Liu Hematology at Southern Medical University conducted an open randomized Phase 3 trial to assess the efficacy and tolerance of Solafini maintenance therapy after transplantation of hematopoietic stem cells from these patients.
end of the year is the cumulative recurrence rate of 1 year.
the trial recruited patients with acute myeloid leukemia who were 18-60 years old with FLT3-ITD for a planned hematopoietic stem cell transplant, and required ECOG to perform 0-2 points, get complete remission before and after the transplant, and recover hematology within 60 days of the transplant.
June 20, 2015 - July 21, 2018, a total of 202 patients were recruited and randomly assigned to the Solafini Maintenance Group (100, Sorafini 400 mg, oral, 2/day) or control group (102).
21.3 months after transplantation.
1 year cumulative recurrence rate was 7.0% and 24.5%, respectively, in the Solafini and control groups (risk ratio of 0.25).
within 210 days of transplantation, the most common 3/4 adverse reactions were infection (24% vs. 24%), acute graft anti-host disease (GVHD 23% vs 21%), chronic GVHD (18% vs 17%) and blood toxicity (15% vs 7%).
treatment-related deaths.
maintenance therapy after transplantation reduces the recurrence of FLT3-ITD acute myeloid leukemia and is well-to-do.
may be a new treatment option for patients with FLT3-ITD acute myeloid leukemia.
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