South China Children Cancer Group - Relapsed-Acute Lymphoblastic Leukemia 2022 Protocol (SCCCG-R-ALL)

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.

Study Overview

• Status: Recruiting
• Conditions: Childhood ALL; Arsenic Trioxide
• Intervention / Treatment: Combination product: Conventional chemotherapy; Drug: Realgar Indigo naturalis formula

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 Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Pei J Fang, Doctoral; Phone Number: 13682290830; Email: jpfang2005@163.com
• Study Contact Backup: Name: Jian Wang, Master's; Phone Number: 18588935208; Email: 459283765@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Contact: Pei J Fang, Doctoral; Phone Number: 13682290830; Email: jpfang2005@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Oral placebo was added to conventional chemotherapy	Combination product: Conventional chemotherapy; conventional chemotherapy
Experimental: Experimental Group; Oral RIF was added to conventional chemotherapy	Combination product: Conventional chemotherapy; conventional chemotherapy; 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; Other Names: RIF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete response rate	Complete response rate after induction treatment in two groups	from diagnosis, an average of 7 weeks

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Guangzhou First People's Hospital; The First Affiliated Hospital of Guangzhou Medical University; Zhujiang Hospital; Third Affiliated Hospital, Sun Yat-Sen University; Second Xiangya Hospital of Central South University; Huizhou Municipal Central Hospital; First Affiliated Hospital of Shantou University Medical College; Zhongshan People's Hospital, Guangdong, China; Hainan People's Hospital; First Affiliated Hospital of Guangxi Medical University; LiuZhou People's Hospital; Zhongshan Bo Ai Hospital
• Investigators: Study Chair: Xin Y Chen, Doctoral, Medical Ethics Committee of Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2022
• Primary Completion (Anticipated): September 27, 2027
• Study Completion (Anticipated): September 27, 2030

Study Registration Dates

• First Submitted: January 2, 2023
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
• Other Study ID Numbers: SYSKY-2022-201-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No