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

Recruiting Phase 1 Phase 2 Interventional Study
Newly Diagnosed Acute Myeloid Leukemia (AML)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 59
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
58 (estimated)
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
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About This Trial
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 cytarabi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Subject has a diagnosis of previously-untreated de novo acute myeloid leukemia (AML) \> 20% blasts in the bone marrow according to WHO classification (2016) documented prior to enrollment.; 2. Age ≥ 18 and \< 60 years; 3. Subjects who are positive for FLT3 mutations by centra…
Contacts

Liu Ting, Chief doctor

+8618980601240

liuting@scu.edu.cn

CONTACT

Wang Jianxiang, Chief doctor

wangjx@ihcams.ac.cn

CONTACT