Actively Recruiting
SKLB1028, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Led by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Updated on 2022-07-06
58
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 .
CONDITIONS
Official Title
SKLB1028, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of previously untreated de novo acute myeloid leukemia (AML) with more than 20% blasts in bone marrow
- Age 18 to less than 60 years
- Positive for FLT3 mutations by central laboratory
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Liver and kidney function within specified limits: total serum bilirubin ≤ 2.5 times upper limit of normal, serum creatinine ≤ 3 times upper limit of normal or estimated glomerular filtration rate > 30 ml/min
- Suitable for oral administration of study drug
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia or BCR-ABL positive leukemia
- Active malignancy other than AML
- AML secondary to prior radiotherapy or chemotherapy for other tumors
- AML with central nervous system involvement
- Refractory hypokalemia or hypomagnesemia not easily corrected
- Current clinically significant graft-versus-host disease
- History of other malignancies
- Clinically significant coagulation disorders such as DIC, hemophilia A or B, or von Willebrand disease
- Recent major surgery or not fully recovered from major surgery
- Prior therapy for AML except emergency leukapheresis, hydroxyurea, growth factor or cytokine support, or steroids for anaphylaxis or transfusion reaction
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, China
Actively Recruiting
Research Team
L
Liu Ting, Chief doctor
CONTACT
W
Wang Jianxiang, Chief doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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