Sunshine Lake Pharma Co., Ltd.
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
Acute Myeloid Leukemia, Adult
Clifutinib Besylate
Phase 1
Phase 2
Main purpose:To evaluate the tolerability and safety of Clifutinib Besylate combined with DA (Cytarabine + Daunorubicin) or AZA (Azacitidine) in newly-treated adult AML subjects; explore reasonable therapeutic doses through climbing tests in different dose groups. To evaluate the efficacy of Clifutinib Besylate combined with DA or AZA in newly treated adult AML subjects. Secondary purpose:To observe the pharmacokinetic (PK) characteristics of Clifutinib combined with DA or AZA in newly-treated adult AML subjects and the drug interaction between Clifutinib and AZA at the same time.Observe the correlation of different subtypes and prognostic risk with the efficacy of Clifutinib and the changes of genes before and after treatment.
Study Type : | Interventional |
Estimated Enrollment : | 133 participants |
Masking: | Single |
Primary Purpose: | Treatment |
Official Title: | A Phase Ib/II, Multi-center, Open Clinical Trial of Crifortinib Besylate Combined With Chemotherapy in Newly-treated Adult Subjects With Acute Myeloid Leukemia |
Actual Study Start Date : | October 1, 2022 |
Estimated Primary Completion Date : | February 18, 2025 |
Estimated Study Completion Date : | October 7, 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm 1 Queue 1:Clifutinib Besylate:30mg qd d8-21;Daunorubicin 60 mg/m2 qd d1-3;Cytarabine 100 mg/m2 qd d1-7 Queue 1:Clifutinib Besylate:30mg qd d1-28 ;Azacitidine 75 mg/m2 qd d1-7 |
Drug: Clifutinib Besylate |
Experimental: Arm 2 Queue 1:Clifutinib Besylate:40mg qd d8-21;Daunorubicin 60 mg/m2 qd d1-3;Cytarabine 100 mg/m2 qd d1-7 Queue 1:Clifutinib Besylate:40mg qd d1-28 ;Azacitidine 75 mg/m2 qd d1-7 |
Drug: Clifutinib Besylate |
Experimental: Arm 3 Queue 1:Clifutinib Besylate:60mg qd d8-21;Daunorubicin 60 mg/m2 qd d1-3;Cytarabine 100 mg/m2 qd d1-7 Queue 1:Clifutinib Besylate:60mg qd d1-28 ;Azacitidine 75 mg/m2 qd d1-7 |
Drug: Clifutinib Besylate |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
the First Affiliated Hospital,College of Medicine,Zhejiang University
Hanzhou, China,