South China Children Cancer Group - Relapsed-Acute Lymphoblastic Leukemia 2022 Protocol
Status:
Recruiting
Trial end date:
2030-09-27
Target enrollment:
Participant gender:
Summary
In recent years, the prognosis of pediatric relapsed ALL patients has improved, but the
5-year OS of patients with first recurrence is still less than 50%. A number of in vitro
studies have shown that arsenic trioxide (ATO) can selectively inhibit the growth and induce
apoptosis in a variety of leukemia cell lines, suggesting that ATO as a synergist combined
with other common chemotherapy drugs may provide a new target for the treatment of relapsed
ALL. Realgar Indigo naturalis formula is a compound traditional Chinese medicine preparation
developed in China. The main component of realgar is arsenic tetrasulfide (As4S4), which can
produce similar pharmacological effects to ATO. Based on the R3 protocol, this study plans to
perform a double-blind randomized controlled trial, and to randomly combine compound Huangdai
tablets with compound Huangdai tablets in the treatment of intermediate and high risk ALL
children, in order to improve the MRD negative rate after induction therapy in this group of
children, which may provide a new method for the clinical treatment of relapsed ALL.
Phase:
Phase 4
Details
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators:
First Affiliated Hospital of Guangxi Medical University First Affiliated Hospital of Shantou University Medical College First Affiliated Hospital, Sun Yat-Sen University Guangzhou First People's Hospital Hainan People's Hospital Huizhou Municipal Central Hospital LiuZhou People's Hospital Second Xiangya Hospital of Central South University The First Affiliated Hospital of Guangzhou Medical University Third Affiliated Hospital, Sun Yat-Sen University Zhongshan Bo Ai Hospital Zhongshan People's Hospital, Guangdong, China Zhujiang Hospital