This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia.
This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia. Selinexor will be given orally at 60mg, d3,10,17 Azacitidine will be given at 75mg/m2, d1-3, 8-9, 15-16 Venetoclax will be given orally at 100mg on day 1 and 200mg on day 2, 400mg on day 3-14 28 days per cycle, patients can receive transplants at any time once they achieved complete remission and other patients will continue to receive treatment until disease progression or unacceptable toxic effects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Selinexor 60mg, PO d3,10,17
Azacitidine 75mg/m2, IV d1-3, 8-9, 15-16
Venetoclax 100mg PO on day 1 and 200mg on day 2, 400mg on day 3-14
Changzhou Municipal No.1 People's Hospital
Changzhou, China
NOT_YET_RECRUITINGPercentage of Participants With Composite Complete Remission
composite complete remission(CR , CRh, CRi) was calculated based on ELN2022 criteria.
Time frame: From the study start up to death (up to approximately 2 years; )
overall survival (OS)
Time frame: From the study start up to death (up to approximately 4 years; )
Overall response rate(ORR)
Time frame: From the study start up to death (up to approximately 4 years; )
percentage of patients who achieved MRD negativity
Time frame: From the study start up to death (up to approximately 4 years; )
Recurrence Free Survival(RFS)
Time frame: From the study start up to death (up to approximately 4 years; )
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