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

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.

Conditions

• Arsenic Trioxide
• Childhood ALL

Interventions

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

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Zhujiang Hospital

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Guangzhou First People's Hospital

  collaborator OTHER

• Huizhou Municipal Central Hospital

  collaborator OTHER

• First Affiliated Hospital of Shantou University Medical College

  collaborator OTHER

• Zhongshan People's Hospital, Guangdong, China

  collaborator OTHER

• Zhongshan Bo Ai Hospital

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• LiuZhou People's Hospital

  collaborator OTHER

• Second Xiangya Hospital of Central South University

  collaborator OTHER

• Hainan People's Hospital

  collaborator OTHER

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

  lead OTHER

Principal Investigators

• Xin Y Chen, Doctoral · Medical Ethics Committee of Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-27

Primary Completion

2027-09-27

Completion

2030-09-27

Countries

• China

Study Locations