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SKLB1028, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

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)

NCT05445154•CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 59 years

Sex

ALL

Healthy Volunteers

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;

Locations (1)

West China Hospital of Sichuan University

Chengdu, China

Key Dates

Start Date

August 31, 2021

Primary Completion Date

October 31, 2024

Completion Date

December 31, 2026

Last Updated

July 6, 2022

Enrollment

ESTIMATED participants

Conditions

Newly Diagnosed Acute Myeloid Leukemia (AML)

Interventions

SKLB1028 Dose Escalation

DRUG

Contacts

Liu Ting, Chief doctor

CONTACT

+8618980601240 liuting@scu.edu.cn

Wang Jianxiang, Chief doctor

CONTACT

wangjx@ihcams.ac.cn

Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation

NCT02632708

Newly Diagnosed Acute Myeloid Leukemia (AML)Untreated AML+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 6, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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