Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children (SCCLG-M5)
Leukemia, Monocytic, Acute, Pediatric AML
About this trial
This is an interventional treatment trial for Leukemia, Monocytic, Acute focused on measuring Acute monocytic leukemia, pediatric, Cladribine, sorafenib
Eligibility 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
Sites / Locations
- Maternal and Child Health Hospital of FoshanRecruiting
- Guangzhou First People's HospitalRecruiting
- The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
- Third Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
- Zhujiang Hospital of Southern Medical UniversityRecruiting
- Guangzhou First People's Hospital First Affiliated Hospital of Shantou University Medical CollegeRecruiting
- Second Xiangya Hospital of Central South UniversityRecruiting
- Jiangxi Province Children's Hospital Southern Medical University, ChinaRecruiting
- The First Affiliated Hospital of Nanchang UniversityRecruiting
Arms of the Study
Arm 1
Experimental
treatment arm
The patients in this arm will receive SCCLG-M5 2022 regimen for newly dignosed acute monocytic leukemia (M5) ,including two courses of CLAG(cladribine, darubicin and cytarabine) in the induction period and followed by three courses(HA1M, HA2E, HA3) in consolidation therapy prescribed as the NOPHO-AML 2004 protocol. The targeted drugs sorafenib 200mg/m2/day orally is used for FLT3 positive acute monocytic leukemia until molecular biology remission for 2 years.