A multicenter, single-arm clinical study of evaluate the efficacy and safety of selinexor combined with venetoclax as maintenance therapy following allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia patients.
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a curative treatment for intermediate- to high-risk acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).However, there are still some patients who relapse after transplantation, resulting in treatment failure. Therefore, post-transplantation maintenance therapy is needed for AML/MDS patients with poor prognosis to further reduce recurrence and prolong survival. In in vitro studies, XPO1 inhibitor combined with venetoclax was found to have a promising anti-leukemic effect, and venetoclax increased ROS levels in the bone marrow microenvironment and improved the post-transplant immune microenvironment. Accordingly, we propose to carry out XPO1 inhibitor combined with venetoclax as maintenance therapy after allo-HSCT in patients with intermediate- to high-risk AML/MDS. There is a lack of prospective, controlled studies to clarify the efficacy and safety of XPO1 inhibitor combined with venetoclax as maintenance therapy after allo-HSCTin patients with intermediate- to high-risk AML/MDS, especially those with out specific gene mutation which would be targeted with commerically available inhibitors. Therefore, this multicenter, single-arm study is designed to assess the efficacy and safety of selinexor combined with venetoclax as maintenance therapy after intermediate to high-risk MDS/AML after allo-HSCT, with the aim of providing a reference for clinical treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
73
After allo-HSCT, intermediate-high risk MDS/AML patients are maintenanced with selinexor given in combination with venetoclax for 2 years
Ruijin Hospital of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Progress-free survival
disease progression or death as a result of any causes
Time frame: through study completion, an average of 2 year
Overall survival
death as a result of any causes
Time frame: through study completion, an average of 2 year
Non-relapse survial
death without disease progression or relapse
Time frame: through study completion, an average of 2 year
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