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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Combination product
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 14
Healthy Volunteers: f
View:

• B or T cell type;

• the first recurrence;

• the risk stratification was medium or high risk.

Locations
Other Locations
China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Pei J Fang, Doctoral
jpfang2005@163.com
13682290830
Backup
Jian Wang, Master's
459283765@qq.com
18588935208
Time Frame
Start Date: 2022-09-27
Estimated Completion Date: 2030-09-27
Participants
Target number of participants: 210
Treatments
Placebo_comparator: Control group
Oral placebo was added to conventional chemotherapy
Experimental: Experimental Group
Oral RIF was added to conventional chemotherapy
Sponsors
Collaborators: First Affiliated Hospital of Shantou University Medical College, Hainan People's Hospital, The First Affiliated Hospital of Guangzhou Medical University, LiuZhou People's Hospital, Second Xiangya Hospital of Central South University, First Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital, Third Affiliated Hospital, Sun Yat-Sen University, Huizhou Municipal Central Hospital, Zhongshan Bo Ai Hospital, Guangzhou First People's Hospital, First Affiliated Hospital of Guangxi Medical University, Zhongshan People's Hospital, Guangdong, China
Leads: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

This content was sourced from clinicaltrials.gov