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
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
43 participants
Dec 1, 2021
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
Inclusion Criteria2
- years old
- Cytologically proven acute monocytic leukemia (M5) with other treatment
Exclusion Criteria8
- 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
Interventions
5ug/kg/day d0-5,if Peripheral blood leukocytes\<20,000/ul
2g/㎡/day d1-5 in 4 hours, after the use of Cladribine
Idarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II
Idarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II
200mg/m2/day was taken orally until molecular biology remission for 2 years
5mg/㎡/day d1-5 in 2 hours, before the use of Cytarabine
Locations(9)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05313958