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Clinical Trials in China / NCT05445154
Recruiting Phase 1/2

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

NCT05445154 · tracked via the Priya Life Science China tracker
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Phase
Phase 1/2
Started
2021-08-31
Last updated
2022-07-06

Condition(s) studied

Newly Diagnosed Acute Myeloid Leukemia (AML)

Investigational drug(s) / intervention(s)

SKLB1028 Dose Escalation

SKLB1028 Dose Escalation: Drug :SKLB1028 ;Drug: Cytarabine ;Drug: Daunorubicin

Study summary

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 .

Eligibility

Sex
ALL
Min age
18 Years
Max age
59 Years
Healthy volunteers
No
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 central laboratory; 4. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; 5. Subject must meet the following criteria as indicated on the clinical laboratory tests; 1. Serum aspartate aminotransf 2. Total serum bilirubin ≤ 2.5 x institutional ULN 3. Serum creatinine ≤ 3 x institutional ULN or an estimated glomerular filtration rate (eGFR) of \> 30 ml/min 6. Subject is suitable for oral administration of study drug. Exclusion Criteria: 1. Confirmed diagnosis of acute promyelocytic leukemia (M3 /APL), or BCR-ABL positive leukemia (ie, blast crisis of chronic myelogenous leukemia); 2. Diagnosis of active malignancy other than AML; 3. AML secondary to radiotherapy or chemotherapy for other tumors; 4. AML with central nervous system involvement; 5. Refractory hypokalemia or hypomagnesemia that is not easily corrected by symptomatic treatment and that occurs repeatedly in the past; 6. Current clinically significant graft-ve 7. Previous history of other malignancies. 8. Patients with clinically significant coagulation abnormalities, such as disseminated intravascular coagulation (DIC), hemophilia A, hemophilia B, and von Willebrand disease; 9. 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 10. 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;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
West China Hospital of Sichuan University Chengdu China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05445154 on ClinicalTrials.gov ↗ ← All trials in China