A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunshine Lake Pharma Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Clifutinib Besylate

Treatment groups

133 Participants
are divided into 3 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

the First Affiliated Hospital,College of Medicine,Zhejiang UniversityRecruiting310003, Hanzhou, ZhejiangChinaChina

Sponsors and collaborators