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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- South China Children Cancer Group - Relapsed-Acute Lymphoblastic Leukemia 2022 Protocol
- ClinicalTrials.gov ID
- NCT05682131
- Acronym / sponsor ID
- SCCCG-R-ALL / SYSKY-2022-201-02
- Conditions
- Arsenic Trioxide, Childhood ALL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, 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
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 27 Sep 2027 (estimated)
- Study completion
- 27 Sep 2030 (estimated)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Combination Product: Conventional chemotherapyOral placebo was added to conventional chemotherapy |
| Experimental Group | Experimental | Drug: Realgar Indigo naturalis formula, Combination Product: Conventional chemotherapyOral RIF was added to conventional chemotherapy |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- B or T cell type;
- the first recurrence;
- the risk stratification was medium or high risk.
Key exclusion criteria (6 listed)
- mature B cell leukemia;
- acute mixed phenotype leukemia;
- patients with positive BCR/ABL fusion gene;
- the second tumor
- definite CML blast crisis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Realgar Indigo naturalis formulaAlso: RIFRealgar Indigo naturalis formula was used in the induction, consolidation and intensive treatment of patients in intermediate or high risk | Drug | Experimental Group |
| Conventional chemotherapyconventional chemotherapy | Combination product | Control group, Experimental Group |
Primary outcome
Complete response rate
Time frame: from diagnosis, an average of 7 weeks
Complete response rate after induction treatment in two groups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Arsenic Trioxide
Not yet recruitingPhase 2
Arsenic Trioxide Combined With Chemotherapy for Relapsed SHH-Activated and/or TP53-Mutant Medulloblastoma
Medulloblastoma
Not yet recruitingPhase 1
Arsenic Trioxide to Prevent Relapse in Patients Undergoing Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia or Myelodysplastic Syndrome
Acute Myeloid Leukemia, Myelodysplastic Syndrome
RecruitingPhase 2
Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
Acute Promyelocytic Leukemia With PML-RARA
Active, not recruitingPhase 3
Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia
Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA
Not yet recruitingPhase 3
A Trial to Investigate Whether Oral Arsenic Trioxide Is Similar to Intravenous Arsenic Trioxide in Pharmacokinetics, Safety, and Efficacy (LATITUDE/SDKARS-301)
Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xin Y Chen, Doctoral study chair
Medical Ethics Committee of Sun Yat-sen Memorial Hospital of Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pei J Fang, Doctoral (13682290830, jpfang2005@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: from diagnosis, an average of 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.