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

Recruiting now · Phase 1/Phase 2

Conditions studied: Newly Diagnosed Acute Myeloid Leukemia (AML)

In brief

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 .

Key facts

Study ID

NCT05445154

Run by

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

People needed

58

Starts

2021-08-31

Expected to finish

2026-12-31

Last updated by the study team

2022-07-06

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.;
• Age ≥ 18 and < 60 years;
• Subjects who are positive for FLT3 mutations by central laboratory;
• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
• Subject must meet the following criteria as indicated on the clinical laboratory tests;
• Serum aspartate aminotransf
• Total serum bilirubin ≤ 2.5 x institutional ULN
• Serum creatinine ≤ 3 x institutional ULN or an estimated glomerular filtration rate (eGFR) of > 30 ml/min
• Subject is suitable for oral administration of study drug.

You may not qualify if…

• Confirmed diagnosis of acute promyelocytic leukemia (M3 /APL), or BCR-ABL positive leukemia (ie, blast crisis of chronic myelogenous leukemia);
• Diagnosis of active malignancy other than AML;
• AML secondary to radiotherapy or chemotherapy for other tumors;
• AML with central nervous system involvement;
• Refractory hypokalemia or hypomagnesemia that is not easily corrected by symptomatic treatment and that occurs repeatedly in the past;
• Current clinically significant graft-ve
• Previous history of other malignancies.
• Patients with clinically significant coagulation abnormalities, such as disseminated intravascular coagulation (DIC), hemophilia A, hemophilia B, and von Willebrand disease;
• Major surgery of major organs has been performed before entering the study (for the definition of major surgery, refer to Grade 3 and 4 surgery specified in Management Measures for Clinical Application of Medical Technology, or the patient has not yet fully recovered from
• Subject has received prior therapy for AML with the following exceptions: a. emergency leukapheresis; b. emergency treatment with hydroxyurea ;c. growth factor or cytokine support; d. steroid for anaphylaxis or transfusion reaction;

Where it is running

• West China Hospital of Sichuan University — Chengdu, China (enrolling)

Full record on ClinicalTrials.gov

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