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Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children

RECRUITINGPhase 2/3Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Actively Recruiting
PhasePhase 2/3
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Started2021-12-01
Est. completion2026-03-30
Eligibility
Age1 Month – 14 Years
Healthy vol.Accepted

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

Age: 1 Month – 14 YearsHealthy volunteers accepted
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

Conditions3

CancerLeukemia, Monocytic, AcutePediatric AML

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