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

Recruiting now · Phase 4

Conditions studied: Arsenic Trioxide, Childhood ALL

In brief

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.

Key facts

Study ID

NCT05682131

Run by

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

People needed

210

Starts

2022-09-27

Expected to finish

2030-09-27

Last updated by the study team

2023-01-12

Who can join

Age: 1 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• B or T cell type;
• the first recurrence;
• the risk stratification was medium or high risk.

You may not qualify if…

• 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.

Where it is running

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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