Tests SKLB1028 with chemotherapy in newly diagnosed acute myeloid leukemia
Tests SKLB1028 combined with standard chemotherapy in adults newly diagnosed with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: SKLB1028, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Key facts
- Where
- Chengdu, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults under 60 with newly diagnosed acute myeloid leukemia (AML) who have a FLT3 mutation and have not been treated yet.
- Age
- 18 years to under 60 years
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed AML, not treated before, with more than 20% blasts in the bone marrow. ECOG performance status 2 or lower.
- Earlier treatment
- No earlier treatment for AML. Only emergency leukapheresis, emergency hydroxyurea, growth factor or cytokine support, and steroids for an allergic or transfusion reaction are allowed.
- Biomarker or test result
- Positive for FLT3 mutations, confirmed by the central laboratory.
Main reasons for not taking part
- Acute promyelocytic leukemia (M3/APL) or BCR-ABL positive leukemia
- AML caused by earlier radiotherapy or chemotherapy for other tumors
- AML that has spread to the central nervous system
- Another active cancer, or a history of other cancers
- Serious blood clotting problems, such as DIC, hemophilia A or B, or von Willebrand disease
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 59 years old?
Source: NCT05445154, who can take part
Where in China
- West China Hospital of Sichuan UniversityChengdu, ChinaContact: Liu Ting, Chief doctorTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Trial code
- NCT05445154
- Record updated
- 6 July 2022
- Original description
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 .Read full original descriptionShow less
A Single-Arm, Multicenter, Open-Label, Dose- Escalating and Expanding,Phase I/II Study of SKLB1028 Combined With "7+3" Standard Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
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 .
Inclusion: 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.
Exclusion: AML secondary to radiotherapy or chemotherapy for other tumors; 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; Diagnosis of active malignancy other than AML; 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; Confirmed diagnosis of acute promyelocytic leukemia (M3 /APL), or BCR-ABL positive leukemia (ie, blast crisis of chronic myelogenous leukemia); 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.