South China Children Cancer Group - Relapsed-Acute Lymphoblastic Leukemia 2022 Protocol

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.

NCT Number	NCT05682131
Lead Sponsor	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Collaborators: First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou First People's Hospital, Huizhou Municipal Central Hospital, First Affiliated Hospital of Shantou University Medical College, Zhongshan People's Hospital, Guangdong, China, Zhongshan Bo Ai Hospital, First Affiliated Hospital of Guangxi Medical University, LiuZhou People's Hospital, Second Xiangya Hospital of Central South University, Hainan People's Hospital
Conditions	Arsenic Trioxide, Childhood ALL
Enrollment	210 participants
Start Date	2022-09-27
Primary Completion	2027-09-27 (estimated)
Study Completion	2030-09-27 (estimated)
Updated on ClinicalTrials.gov	2023-01-12