Lancet oncol: Liu-Inspired Team - Phase III Clinical Trials - AML After Transplantation, Sorafini is used to maintain the efficacy and tolerability of the treatment.

Retrospective results showed that Sorafini maintenance therapy or reduced recurrence after transplantation of heteroglytic stem cells in patients with acute myeloid leukemia carrying FLT3-ITD internal series repetition (FLT3-ITD).
, director of haematology at Southern Medical University, led an open, randomized Phase 3 trial to assess the efficacy and tolerability of Sorafini maintenance therapy after hematopoietic stem cell transplantation in such patients.
end point is a cumulative recurrence rate of 1 year.
The trial recruited acute myeloid leukemia patients aged 18-60 with FRT3-ITD who were planning an allogygenic hematopoietic stem cell transplant and required ECOG performance of 0-2 points, full remission before and after the transplant, and hematological recovery within 60 days of transplantation.
June 20, 2015 - July 21, 2018, 202 patients were recruited and randomly assigned to the Sorafini maintenance group (100, Sorafini 400 mg, oral, 2/day) or control group (102).
follow-up for 21.3 months after transplantation.
7.0 per cent and 24.5 per cent, respectively, in the Sorafini and control groups (risk ratio of 0.25).
During the 210 days after transplantation, the most common level 3/4 adverse reactions were infection (24% vs 24%), acute graft anti-host disease (GVHD 23% vs 21%), chronic GVHD (18% vs 17%) and hemotoxicity (15% vs 7%).
no treatment-related deaths.
after transplantation, Solafini maintenance therapy reduces the recurrence of FRT3-ITD acute myeloid leukemia and is well tolerated.
may be a new treatment option for patients with FRT3-ITD acute myeloid leukemia.
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