This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor combined with chidamide in the treatment of unfit R/R AML.
This protocol corresponds to a multicenter, open-label, single arm, prospective study designed to determine the efficacy and safety of selinexor in combination with chidamide for unfit R/R AML. Selinexor will be given orally at 40 or 60mg on d1,4,8,11; Chidamide will be given orally at 10mg on d1-28; 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. After completion of study treatment, participants are followed up every 3 to 6 months for up to 2 years. Study design allows 42 patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGNumber of Participants With ORR
Defined as complete response (CR) + CR with incomplete blood count recovery (CRi) + morphologic leukemia-free state (MLFS) + partial response (PR).
Time frame: 28 days after study treatment
Duration of Response (DOR)
Defined as time, in months, from initial response (CR+CRi+PR+MLFS) until the date of a disease progression
Time frame: 2 years
Event-free survival (EFS)
Defined as the number of days from the date of treatment initiation (i.e., course 1 day 1) to the date of documented treatment failure, relapses from CR, or death from any cause, whichever occurs first. Will be calculated for all patients. Estimated using Kaplan-Meier method. Log-rank tests will be used to compare among subgroups of patients.
Time frame: Time from registration to event, max 3 years
Overall Survival (OS)
Calculated from the date of informed consent to the date of death. Patients still alive at the end of follow-up were censored at the last date of follow-up. Estimated using Kaplan-Meier method. Log-rank tests will be used to compare among subgroups of patients.
Time frame: Time from registration to event, max 3 years
Number of Adverse Events (AE)
Adverse events are evaluated with CTCAE V5.0.
Time frame: continuously from first administration of study drug untill 30 days after last study treatment. (approximately up to 1 year)
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