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

Phase 4

Recruiting

• Conditions: Arsenic Trioxide; Childhood ALL
• Interventions: Combination Product: Conventional chemotherapy; Drug: Realgar Indigo naturalis formula

• Registration Number: NCT05682131
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief 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.

Detailed Description

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%, and the prognosis of children with intermediate and high risk is even worse, so there is an urgent need to explore new and effective treatment methods. A number of in vitro studies have shown that arsenic trioxide (ATO), which is safe and effective in the treatment of APL, 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. The UK ALL R3 protocol is an advanced and mature clinical trial. The results showed that the MRD negative rate after induction chemotherapy and the 2-year DFS of traditional chemotherapy ±HSCT in children with intermediate and high risk did not reach 50%. 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.

Study Timeline

• Study Start: 2022-09-27
• Status Verified: 2022-12
• Study First Submitted: 2023-01-02
• Study First Submitted QC: 2023-01-10
• Last Update Submitted: 2023-01-10
• Study First Posted: 2023-01-12
• Last Update Posted: 2023-01-12
• Primary Completion: 2027-09-27
• Study Completion: 2030-09-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Conventional chemotherapy	Oral placebo was added to conventional chemotherapy
Experimental Group	Realgar Indigo naturalis formula	Oral RIF was added to conventional chemotherapy
Experimental Group	Conventional chemotherapy	Oral RIF was added to conventional chemotherapy

Primary Outcome Measures

Name	Time	Method
Complete response rate	from diagnosis, an average of 7 weeks	Complete response rate after induction treatment in two groups

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China