RecruitingPhase 2Phase 3NCT05313958

Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children

Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children: A Prospective Multicenter Study in South China


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

43 participants

Start Date

Dec 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, single arm, prospective, intervention trial. Since cladribine can enhance the biological activity and self-protection of cytarabine, giving cladribine and cytarabine together may kill more cancer cells. 10 centers from South China Childhood Leukaemia Collaborative Group carry out the SCCLG-M5-2022 regimen including two courses of CLAG(cladribine, darubicin and cytarabine) in the induction period for the treatment of newly dignosed acute monocytic leukemia (M5). The targeted drugs sorafenib is used for FLT3 positive acute monocytic leukemia to inhibit the serine / threonine kinase activity of FLT3.


Eligibility

Min Age: 1 MonthMax Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This study is developing and testing a treatment protocol for children newly diagnosed with acute monocytic leukemia (M5), a specific type of acute myeloid leukemia (AML) that mainly affects young children and can be aggressive. **You may be eligible if...** - You are a child between 0 and 14 years old - You have been diagnosed with acute monocytic leukemia (M5 subtype) confirmed by bone marrow analysis **You may NOT be eligible if...** - Your leukemia developed as a result of another condition (like an immune deficiency or myelodysplastic syndrome) - You have a second separate cancer - You have Down syndrome - Your leukemia developed from chronic myelogenous leukemia progressing to blast crisis - You die or stop treatment within the first 7 days of starting induction therapy - You are already being treated with other effective chemotherapy drugs for AML (other than drugs given to lower very high white blood cell counts) - You have severe uncontrolled heart, brain, liver, or kidney failure 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

DRUGG-CSF

5ug/kg/day d0-5,if Peripheral blood leukocytes\<20,000/ul

DRUGCytarabine

2g/㎡/day d1-5 in 4 hours, after the use of Cladribine

DRUGIdarubicin

Idarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II

DRUGMitoxantrone

Idarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II

DRUGSorafenib

200mg/m2/day was taken orally until molecular biology remission for 2 years

DRUGCladribine

5mg/㎡/day d1-5 in 2 hours, before the use of Cytarabine


Locations(9)

Maternal and Child Health Hospital of Foshan

Foshan, Guangdong, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Third Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Guangzhou First People's Hospital First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

Jiangxi Province Children's Hospital Southern Medical University, China

Nanchang, Jiangxi, China

Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

View Full Details on ClinicalTrials.gov

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NCT05313958


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