Actively Recruiting
South China Children Cancer Group - Relapsed-Acute Lymphoblastic Leukemia 2022 Protocol
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2023-01-12
210
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor
F
First Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
South China Children Cancer Group - Relapsed-Acute Lymphoblastic Leukemia 2022 Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of B or T cell type acute lymphoblastic leukemia
- Experiencing the first recurrence of ALL
- Classified as intermediate or high risk for ALL
You will not qualify if you...
- Diagnosis of mature B cell leukemia
- Diagnosis of acute mixed phenotype leukemia
- Positive for BCR/ABL fusion gene
- Having a second tumor
- Diagnosed with chronic myeloid leukemia blast crisis
- ALL with Down's syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
P
Pei J Fang, Doctoral
CONTACT
J
Jian Wang, Master's
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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