Randomized Trial of Sorafenib Prophylaxis After Allogeneic Hematopoietic Stem Cell Transplantation With Post-transplantation Bendamustine and Cyclophosphamide
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.
• Patients must have high-risk myeloid malignancy as an indication for transplantation defined as:
‣ acute myeloid leukemia not in hematological remission prior to transplantation,
⁃ ≥ 3 remission of acute myeloid leukemia,
⁃ any myeloid malignancy with bi-allelic tp53 mutation,
⁃ any myeloid malignancy with complex karyotype,
⁃ therapy-related myeloid malignancy not in MRD-negative response
⁃ myelodysplastic syndrome with very high IPSS-R risk
⁃ any myeloid malignancy with monosomal or t(3;3) karyotype,
⁃ any myeloid malignancy with ASXL1, bi-allelic tp53 or RUNX1 mutation, EVI1 overexpression
⁃ MDS/NPM unclassified not in hematologic remission.
• Documented hematological remission in the bone marrow at the time of inclusion post-engraftment, measurable residual disease is allowed
• First 100 days after allogeneic hematopoietic stem cell transplantation