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

• Status: Recruiting
• Trial end date: 2030-09-27
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• B or T cell type;

• the first recurrence;

• the risk stratification was medium or high risk.

Exclusion Criteria:

• mature B cell leukemia;

• acute mixed phenotype leukemia;

• patients with positive BCR/ABL fusion gene;

• the second tumor

• definite CML blast crisis;

• ALL with Down's syndrome.