New treatment approach for relapsed childhood leukemia using arsenic compounds
Official title: South China Children Cancer Group - Relapsed-Acute Lymphoblastic Leukemia 2022 Protocol
Run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · NCT05682131 · Data updated 2026-11-12
This study is testing a new treatment using arsenic compounds combined with standard chemotherapy to see if it can help children with relapsed acute lymphoblastic leukemia feel better and have a better chance of recovery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 1 Year to 14 Years |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | September 27, 2022 |
| Main results expected | September 27, 2027 |
| Study ends | September 27, 2030 |
| Registry record updated | January 12, 2023 |
| Trial ID | NCT05682131 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children diagnosed with B or T cell type relapsed ALL who are experiencing their first recurrence and are classified as medium or high risk.
✕Probably not a fit
Patients with mature B cell leukemia, acute mixed phenotype leukemia, or those with specific genetic markers like the BCR/ABL fusion gene will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the efficacy of arsenic trioxide (ATO) and a traditional Chinese medicine formula, Realgar Indigo naturalis, in treating children with relapsed acute lymphoblastic leukemia (ALL). The study aims to improve the minimal residual disease (MRD) negative rate after induction therapy by combining these treatments with conventional chemotherapy. It employs a double-blind randomized controlled design to ensure unbiased results and focuses on children classified as intermediate or high risk. The trial is based on previous findings that suggest ATO can inhibit leukemia cell growth and induce cell death.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and outcomes for children with relapsed ALL.
How similar studies have gone: Previous studies have shown promising results with arsenic-based treatments in leukemia, indicating potential for success in this novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Pei J Fang, Doctoral
- Email: jpfang2005@163.com
- Phone: 13682290830
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.