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SKLB1028, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

StatusRecruiting
PhasePhase 1/2
Started2021-08-31
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 6, 2022 (before its estimated October 31, 2024 completion). Its status may not reflect the trial's current state.
The purpose of this study is to describe the dose limiting toxicities (DLT) of SKLB1028 when combined with cytarabine/ daunorubicin remission induction in a 7+3 schedule. Safety and tolerability of SKLB1028 will also be evaluated. This study will also characterize the pharmacokinetics (PK) of SKLB1028 when given in combination with cytarabine/daunorubicin remission induction and high-dose cytarabine (HiDAC) consolidation therapy in newly diagnosed acute myeloid leukemia .
Trial Details
NCT Number NCT05445154
Lead Sponsor CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions Newly Diagnosed Acute Myeloid Leukemia (AML)
Enrollment 58 participants
Start Date 2021-08-31
Primary Completion 2024-10-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2022-07-06