Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children

• Status: Recruiting
• Trial end date: 2026-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Collaborators: First Affiliated Hospital of Shantou University Medical College; Guangzhou First People's Hospital; Jiangxi Province Children's Hospital; Maternal and Child Health Hospital of Foshan; Second Xiangya Hospital of Central South University; Southern Medical University, China; The First Affiliated Hospital of Guangzhou Medical University; The First Affiliated Hospital of Nanchang University; Third Affiliated Hospital, Sun Yat-Sen University
• Treatments: Cladribine; Cytarabine; Idarubicin; Mitoxantrone; Sorafenib

Criteria

Inclusion Criteria:

0-14 years old

Cytologically proven acute monocytic leukemia (M5) with other treatment

Exclusion Criteria:

Secondary to immunodeficiency or MDS

Second tumor

Dowm's syndrome

Evolution of chronic myelogenous leukemia to blast crisis

Death or quit treatment in seven days at the begining of induction therapy

Treatment with other effective chemotherapy drugs for AML, excluding the low dose chemotherapy for the purpose of reducing leukocytes in hyperleukocytic leukemia

Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled heart, brain, liver and kidney failure etc.)

Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule