RecruitingPhase 1Phase 2NCT05445154

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)


Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Enrollment

58 participants

Start Date

Aug 31, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 59 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination of three drugs — SKLB1028, daunorubicin, and cytarabine — as initial treatment (induction therapy) for adults with newly diagnosed acute myeloid leukemia (AML) that has a specific FLT3 gene mutation. **You may be eligible if...** - You are between 18 and 60 years old - You have been newly diagnosed with AML (have not received prior AML treatment) - Your AML tests positive for a FLT3 gene mutation - You are in good enough health to receive intensive chemotherapy - You can swallow the study drug orally **You may NOT be eligible if...** - You have received prior treatment for AML - You are over 60 years old - You have significant liver, kidney, or heart problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSKLB1028 Dose Escalation

Drug :SKLB1028 ;Drug: Cytarabine ;Drug: Daunorubicin


Locations(1)

West China Hospital of Sichuan University

Chengdu, China

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NCT05445154


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