This is a single-center randomized open-label phase II clinical trial to compare relapse prophylaxis with sorafenib and observation after graft-versus-host disease prophylaxis with post-transplantation bendamustine and cyclophosphamide in high-risk myeloid malignancies. This is an intention to treat study, where randomization is performed at first documentation of CR after engraftment.
Patients must undergo allogeneic hematopoietic stem cell transplantation with post-transplantation bendamustine AND cyclophosphamide from any donor.
acute myeloid leukemia not in hematological remission prior to transplantation,
≥ 3 remission of acute myeloid leukemia,
any myeloid malignancy with bi-allelic tp53 mutation,
successfully treated relapse between transplantation and enrollment
use of any other planned method for prophylaxis of relapse besides sorafenib
donor lymphocyte infusion prior to randomization
Second malignancy not in complete remission within 6 months prior to randomization