New treatment approach for relapsed childhood leukemia using arsenic compounds
South China Children Cancer Group - Relapsed-Acute Lymphoblastic Leukemia 2022 Protocol
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 |
| Enrollment | 210 (estimated) |
| Ages | 1 Year to 14 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05682131 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have shown promising results with arsenic-based treatments in leukemia, indicating potential for success in this novel approach.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.