Trial Title:
South China Children Cancer Group - Relapsed-Acute Lymphoblastic Leukemia 2022 Protocol
NCT ID:
NCT05682131
Condition:
Arsenic Trioxide
Childhood ALL
Conditions: Official terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Realgar Indigo naturalis formula
Description:
Realgar Indigo naturalis formula was used in the induction, consolidation and intensive
treatment of patients in intermediate or high risk
Arm group label:
Experimental Group
Other name:
RIF
Intervention type:
Combination Product
Intervention name:
Conventional chemotherapy
Description:
conventional chemotherapy
Arm group label:
Control group
Arm group label:
Experimental Group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
1 Year
Maximum age:
14 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Recruiting
Contact:
Last name:
Pei J Fang, Doctoral
Phone:
13682290830
Email:
jpfang2005@163.com
Start date:
September 27, 2022
Completion date:
September 27, 2030
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Third Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Zhujiang Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Guangzhou First People's Hospital
Agency class:
Other
Collaborator:
Agency:
Huizhou Municipal Central Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Shantou University Medical College
Agency class:
Other
Collaborator:
Agency:
Zhongshan People's Hospital, Guangdong, China
Agency class:
Other
Collaborator:
Agency:
Zhongshan Bo Ai Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Guangxi Medical University
Agency class:
Other
Collaborator:
Agency:
LiuZhou People's Hospital
Agency class:
Other
Collaborator:
Agency:
Second Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
Hainan People's Hospital
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05682131
