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

Childhood ALL Clinical Trial

— SCCCG-R-ALL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05682131
• Other study ID #: SYSKY-2022-201-02
• Status: Recruiting
• Phase: Phase 4
• Start date: September 27, 2022
• Est. completion date: September 27, 2030

Study information

• Verified date: December 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Pei J Fang, Doctoral
• Phone: 13682290830
• Email: jpfang2005[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: September 27, 2030
• Est. primary completion date: September 27, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arsenic Trioxide
• Childhood ALL
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Realgar Indigo naturalis formula
Realgar Indigo naturalis formula was used in the induction, consolidation and intensive treatment of patients in intermediate or high risk

Combination Product:
• Conventional chemotherapy
conventional chemotherapy

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (14)

Lead Sponsor

Collaborator

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

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate	Complete response rate after induction treatment in two groups	from diagnosis, an average of 7 weeks