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 based on MRD results on day 14 of the first cycle.
Azacitidine and Venetoclax will be given at the approved dose regimen for 75mg/m2, d1-7(azacitidine) and 100mg on day 1 and 200mg on day 2, 400mg on day 3-28 (venetoclax), 28 days per cycle. Based on MRD results on C1D14, MRD negative patients will go on azacitidine and venetoclax regimen and for patients with MRD positive, selinexor 60mg on D15 and D22 will be added. 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
75mg/m2 d1-7
d1 100mg, d2 200mg, d3-28 400mg
if MRD positive in C1D14, selinexor 60mg D15, D22
Beizhan Hospital
Shanghai, China
NOT_YET_RECRUITINGPla Navy Feature Medical Center
Shanghai, China
NOT_YET_RECRUITINGShanghai Ruijin Hospital
Shanghai, China
NOT_YET_RECRUITINGShanghai Tong Ren hospital
Percentage of Participants With Composite Complete Remission
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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Shanghai, China