this is a single-arm, open, multicenter, phase 2 study to evaluate the efficacy, safety and pharmacokinetics of HYLM-122 monotherapy in Chinese subjects with FLT3 positive relapsed or refractory acute myeloid leukemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
each treatment cycle is comprised of 28-day consecutive dosing of HYML-122. Upon completion of each cycle, patients may continue to receive oral HYML-122 tablets if they are benefit from the treatment and the toxicity is tolerable.
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGORR
overall remission rate, including complete remission without minimum residual disease (CRMRD-), complete remission (CR), complete remission with incomplete hematologic recovery (CRi), complete remission without platelet recovery (CRp), partial remission (PR).
Time frame: up to 24 months
composite complete remission (CRc) rate
CRc rate is defined as the rate of all complete and incomplete remission (CRMRD-+CR+CRp+CRi).
Time frame: up to 24 months.
RFS
relapse-free survival, for patients achieving a complete remission, defined as the interval from the date of first documentation of a leukemia free state to date of recurrence, treatment failure, death due to any cause or last contact of the end-of-study follow up, which ever occurs first.
Time frame: up to 24 months
EFS
event-free survival, EFS is defined as the time from the date of enrollment until the date of documented relapse from CR, CRp or CRi, treatment failure, death from any cause or last contact of the end-of-study follow-up, whichever occurs first.
Time frame: up to 24 months
OS
overall survival, OS is defined as time from the date of enrollment until the date of death from any cause. For a subject who is not known to have died buy the end-of-study follow-up, OS is censored at the date of last contact.
Time frame: up to 24 months
duration of CR remission
DOR-CR is defined as the time from the date of first CR, CRp, CRi until the date of documented relapse.
Time frame: up to 24 months
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Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
safety and tolerability of investigational product assessed as the number of participants experience adverse events (AEs, CTCAE 5.0) or abnormalities in vital signs, laboratory tests, or electrocardiograms.
Time frame: up to 24 months
Cmax,ss
Peak plasma concentration at steady state
Time frame: at the end of Cycle 1 (each cycle is 28 days)
Cmin,ss
Minimum plasma concentration at steady state
Time frame: at the end of Cycle 1 (each cycle is 28 days)
Cav,ss
The average steady-state plasma concentration
Time frame: at the end of Cycle 1 (each cycle is 28 days)
AUCss
The area under the plasma concentration at steady state
Time frame: at the end of Cycle 1 (each cycle is 28 days)