This is a single-arm, open, multicenter, phase 2 study to evaluate the efficacy, safety and pharmacokinetics of HYLM-122 in combination with cytarabine in Chinese subjects with FLT3 positive relapsed or refractory acute myeloid leukemia.
This study will have two phases. Phase 1: the escalation phase is to establish the recommended phase 2 dose (RP2D) of HYML-122 given in combination with cytarabine. Phase 2: the extension phase study will treat patients with FLT3 positive relapsed or refractory AML with HYML-122 in combination with cytarabine at the RP2D, and further evaluate efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
HYML-122 is administered orally consecutive with 400mg bid or 600mg bid or dose adjusted by DMC judgement in each 28-day treatment cycle. cytarabine is administered by intravenous infusion with 100mg/m2 or dose adjusted by DMC judgement once daily on the first to 7th day of each treatment cycle. Upon completion of each 28-day treatment cycle, patients may continue to receive HYML-122 and cytarabine 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
DOR-CR
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 (TEAEs)
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 (Cmax,ss)
Time frame: at the end of Cycle 1 (each cycle is 28 days)
Cmin,ss
minimum observed plasma concentration at steady state (Cmin,ss) of drug in blood plasma
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)