This is a multi-center open clinical study aimed at evaluating the efficacy and safety of Clifutinib Besylate combined with chemotherapy in newly-treated adult subjects with AML
1.Cohort 1: 18 years old ≤ age ≤65 years old;Cohort 2: The dose escalation trial only included AML subjects aged ≥60 years; the extended trial included subjects who were ≥60 years old or between 18 and 59 years old (including 18 and 59 years old) and could not tolerate strong chemotherapy.
1.Diagnosed as APL and manifested as t(15;17)(q22;q12) chromosomal translocation, or BCR-ABL positive leukemia；Diagnosed as secondary to AML due to previous chemotherapy or radiotherapy of other tumors; previously received FLT3 inhibitor.
Sequential
Clifutinib Besylate
DrugThe queue 1 is divided into Induction therapy and Consolidation therapy and Maintenance treatment The queue 2 will receive oral Clifutinib Besylate once daily until disease progression or unacceptable toxicity occurs
Maximum tolerated dose(MTD)
Safety and Tolerability assessed through adverse events to determine maximum tolerated dose
Composite CR rate
CR + CRi +CRMRD-
Duration of response
The time from receive CR / CRi/CRMRD-/PR to relapse
Objective response rate
CR + CRi +CRMRD- + PR
Event Free Survival
From the first time taking experimental drug to treatment failure or progression or relapse or death
Overall Survival
From the first time taking experimental drug to death
Map coordinates are unavailable for these locations. Locations are shown below instead.
ChinaClick on the lead sponsor to view all of their trials.
