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
Parallel
Sorafenib
DrugSorafenib 200 mg bid for 168 days starting in the time fram between engraftment with neutrophils \> 1.0 x 10\^9/L, white blood cells\> 1.5 x 10\^9/L, platelets\> 1.5 x 10\^9/L and day+100 after allogeneic hematopoietic cell trnaplantation
Event-free survival
Kaplan-Meier estimate of either relapse or secondary graft failure or death from all causes
Overall survival
Kaplan-Meier estimate of death from all causes
Cumulative incidence of primary and secondary graft failure
Cumulative secondary graft failure, competing risk is death and relapse
Incidence of HCT-associated adverse events
Toxicity assessment is based on presence of NCI CTC AE 5.0 event grades 3-5. Veno-occlusive disease incidence and severity assessment is based on EBMT criteria 2020. Transplant-associated microangiopathy incidence assessment is based on Harmonization criteria. All toxicity measurements will be aggregated as severity scores.
Infectious complications, including analysis of severe bacterial, fungal and viral infections incidence
proportion of patients, requiring systemic treatment for bacterial, viral and fungal diseases
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