Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children： A Prospective Multicenter Study in South China
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 14
Healthy Volunteers: f
View:
• 0-14 years old
• Cytologically proven acute monocytic leukemia (M5) with other treatment
Locations
Other Locations
China
Second Xiangya Hospital of Central South University
RECRUITING
Changsha
Maternal and Child Health Hospital of Foshan
RECRUITING
Foshan
Guangzhou First People's Hospital
RECRUITING
Guangzhou
The First Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Third Affiliated Hospital, Sun Yat-Sen University
RECRUITING
Guangzhou
Zhujiang Hospital of Southern Medical University
RECRUITING
Guangzhou
Jiangxi Province Children's Hospital Southern Medical University, China
RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Guangzhou First People's Hospital First Affiliated Hospital of Shantou University Medical College
RECRUITING
Shantou
Contact Information
Primary
dunhua zhou, M.D
zdunhua@163.com
13560099258
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 43
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: The First Affiliated Hospital of Nanchang University, First Affiliated Hospital of Shantou University Medical College, The First Affiliated Hospital of Guangzhou Medical University, Southern Medical University, China, Jiangxi Province Children's Hospital, Second Xiangya Hospital of Central South University, Maternal and Child Health Hospital of Foshan, Guangzhou First People's Hospital, Third Affiliated Hospital, Sun Yat-Sen University
Leads: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University