About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
de novo AML in the ELN2022 high-risk group or MDS in the IPSS-M intermediate-high/high/very-high risk group
Age 18-75 years old, gender is not limited
First hematopoietic stem cell transplant with at least one eligible donor
ECOG physical status score of 0-2
Disqualifiers
bone marrow examination after allo-HSCT suggestive of relapse or measurable residual disease (MRD) before the initiation of maintenance therapy;
Other malignant tumors within 5 years prior to screening, except adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancers, post-radical thyroid cancer, and post-radical ductal carcinoma in situ;
Current active cardiovascular disease of clinical significance, such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional class, or a history of myocardial infarction within the 6 months prior to screening;
Other serious medical conditions that may limit the patient's participation in this trial (e.g., active infection, uncontrolled diabetes);
Trial design
Single group
Treatments tested in this trial
selinexor in combination with venetoclax
DrugAfter allo-HSCT, intermediate-high risk MDS/AML patients are maintenanced with selinexor given in combination with venetoclax for 2 years
Treatment groups
Trial outcomes
Primary outcomes
Progress-free survival
disease progression or death as a result of any causes
Secondary outcomes
Overall survival
death as a result of any causes
Non-relapse survial
death without disease progression or relapse
Sponsors and contacts
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