Patients will receive oral SKLB1028 for 28 days as a course of treatment, and then to evaluate the side effects,tolerability and best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations.
It is an open,multicenter,queue extension study designed to characterize the efficacy and safety of different administration regimens of SKLB1028 capsules in patients with recurrent/refractory acute myeloid leukemia with FLT3 mutation. Divided into three dose groups,150mg BID,200mg BID,300mg QD. The main end point is total remission rate (ORR), total survival time (OS), progress-free survival time (PFS), remission duration, FLT3 suppression rate, competitive parameters, safety (incidence of adverse events).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
150mg oral administration twice a day
200mg oral administration twice a day
300mg oral administration once a day
West China Hospital,Sichuan University
Chengdu, Sichuan, China
Total remission rate (ORR)
Complete remission (CR) + CR with incomplete hematologic recovery (CRi) + complete molecular remission (CRm) + partial remission(PR)
Time frame: Evaluation at the end of each cycle(a cycle is 28 days) of administration and at the end of the study (assessed up to approximately 24 months)
Progression-free survival time (PFS)
Time frame: Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death
Total survival time (OS)
Time frame: 30 days after last subject discontinues treatment (assessed up to approximately 24 months)
CR mitigation duration (DoR-CR)
Time frame: Time from the date at which the patient's objective status is first noted to be a CR to the earliest date progression is documented (assessed up to approximately 24 months
FLT3 inhibition rate
Time frame: Evaluation when the patient's efficacy was evaluated as CR (assessed up to approximately 24 months)
Incidence of adverse events
Time frame: From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)
Vital signs
Time frame: From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)
12-lead ECG
Time frame: From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)
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physical examination
Time frame: From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)
laboratory examination
Time frame: From the start of the study treatment to the end of the study treatment(Within 4 weeks after the last administration)