OncoMatch/Clinical Trials/NCT05682131

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

Is NCT05682131 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies multiple treatments including Realgar Indigo naturalis formula and Conventional chemotherapy for arsenic trioxide.

Treatment: Realgar Indigo naturalis formula · Conventional chemotherapy — 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.