Arsenic TrioxidePhase 4SCCCG-R-ALLNCT05682131
South China Children Cancer Group - Relapsed-Acute Lymphoblastic Leukemia 2022 Protocol
A Phase 4 study testing Realgar Indigo naturalis formula and Conventional chemotherapy in people with Arsenic Trioxide and Childhood ALL, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Arsenic Trioxide, Childhood ALL
- What is being tested?
- Realgar Indigo naturalis formula and Conventional chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2022to 27 Sep 2030
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- B or T cell type;
- the first recurrence;
- the risk stratification was medium or high risk.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Pei J Fang, Doctoral, 13682290830, jpfang2005@163.com
About this study
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.
Read the 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.
- Conditions
- Arsenic Trioxide, Childhood ALL
- Being tested
- Realgar Indigo naturalis formula, Conventional chemotherapy
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Realgar Indigo naturalis formulaDrug
Also called RIF
Realgar Indigo naturalis formula was used in the induction, consolidation and intensive treatment of patients in intermediate or high risk
Conventional chemotherapyCombination product
conventional chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Oral placebo was added to conventional chemotherapy Receives: Combination Product: Conventional chemotherapy |
| Experimental Group | Experimental | Oral RIF was added to conventional chemotherapy Receives: Drug: Realgar Indigo naturalis formula; Combination Product: Conventional chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Complete response rate after induction treatment in two groups
Measured: from diagnosis, an average of 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start27 Sep 2022
- Primary completion27 Sep 2027 (estimated)
- Study completion27 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arsenic TrioxideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou First People's Hospital, Huizhou Municipal Central Hospital, First Affiliated Hospital of Shantou University Medical College, Zhongshan People's Hospital, Guangdong, China, Zhongshan Bo Ai Hospital, First Affiliated Hospital of Guangxi Medical University, LiuZhou People's Hospital, Second Xiangya Hospital of Central South University, Hainan People's Hospital
- Responsible party
- Sponsor
- Investigators
- Xin Y Chen, Doctoral, Study chair, Medical Ethics Committee of Sun Yat-sen Memorial Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682131
- Sponsor's protocol ID
- SYSKY-2022-201-02
- Acronym
- SCCCG-R-ALL
- Status last verified
- Dec 2022
- First submitted
- 2 Jan 2023
- Last updated
- 12 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No