NCT05682131 South China Children Cancer Group - Relapsed-Acute Lymphoblastic Leukemia 2022 Protocol
| NCT ID | NCT05682131 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Condition | Arsenic Trioxide |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2022-09-27 |
| Primary Completion | 2027-09-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 210 participants in total. It began in 2022-09-27 with a primary completion date of 2027-09-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Xin Y Chen, Doctoral
STUDY CHAIR
Medical Ethics Committee of Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT05682131 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 14 Years, studying Arsenic Trioxide. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05682131 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05682131 currently recruiting?
Yes, NCT05682131 is actively recruiting participants. Contact the research team at jpfang2005@163.com for enrollment information.
Where is the NCT05682131 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05682131 clinical trial?
NCT05682131 is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. The principal investigator is Xin Y Chen, Doctoral at Medical Ethics Committee of Sun Yat-sen Memorial Hospital of Sun Yat-sen University. The trial plans to enroll 210 participants.