Allogeneic hematopoietic cell transplantation (allo-HCT) is the only treatment that offers a possible cure for relapsed/refractory AML. Currently, the optimal preallo-HCT bridging regimen for relapsed/refractory AML patients is unclear. Venetoclax-based regimens, including Venetoclax + demethylating agents (HMA) , Venetoclax + HMA + other drugs and Venetoclax-based multidrug combinations as a bridging regimen improves response rate and post-transplant survival in relapsed/refractory AML patients. Therefore, the investigators conduct a prospective single-centre clinical study to evaluate the efficacy and safety of VAH as a transplant bridging regimen for relapsed/refractory AML.
Relapsed/refractory acute myeloid leukaemia has an extremely poor prognosis, and allogeneic haematopoietic stem cell transplantation is the only treatment that offers the possibility of a cure for relapsed/refractory AML. Currently, the optimal pre-allo-HCT bridging regimen for relapsed/refractory AML patients is unclear. Previous studies have found that venetoclax and Azacitidine combined with homoharringtonine (VAH) bridging allogeneic transplantation for relapsed/refractory AML has a post-transplantation CRc of 78% and a 1-year OS of 85%, which is superior to other bridging regimens, and we have also found that VAH has a better safety and efficacy as a pre-transplantation bridging in our previous study. Therefore, the investigators propose to conduct a prospective single-centre clinical study to evaluate the efficacy and safety of VAH as a bridging regimen for transplantation in relapsed/refractory AML. The aim of the study is assessment of the efficacy and safety of allogeneic haematopoietic stem cell transplantation for relapsed/refractory acute myeloid leukaemia in combination with venetoclax and Azacitidine in combination with homoharringtonine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
For R/R AML patients, VAH bridging to conditioning regimen for allo-HCT.
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
2-year post-transplant relapse rate
relapse
Time frame: through study completion, an average of 2 year
2-year event-free survival after transplantation
MRD positivity, relapse, death
Time frame: through study completion, an average of 2 year
Overall survival at 2 years after transplantation
survival
Time frame: through study completion, an average of 2 year
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