Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children

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.

Conditions

• Leukemia, Monocytic, Acute
• Pediatric AML

Interventions

DRUG

Cladribine

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

DRUG

G-CSF

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

DRUG

Cytarabine

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

DRUG

Idarubicin

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

DRUG

Mitoxantrone

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

DRUG

Sorafenib

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

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Maternal and Child Health Hospital of Foshan

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Second Xiangya Hospital of Central South University

  collaborator OTHER

• Jiangxi Province Children's Hospital

  collaborator OTHER

• Southern Medical University, China

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Guangzhou First People's Hospital

  collaborator OTHER

• First Affiliated Hospital of Shantou University Medical College

  collaborator OTHER

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

  lead OTHER

Principal Investigators

• dunha zhou, M.D · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Month

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-01

Primary Completion

2026-03-30

Completion

2026-03-30

Countries

• China

Study Locations