Acute Lymphoblastic Leukemia, PediatricPhase 2/3NCT04228393
The Individualized Treatment of 6-mercaptopurine in Children With Acute Lymphoblastic Leukemia in China
A Phase 2/3 study testing 6-mercaptopurine, Standard treatment and Individualized treatment in people with Acute Lymphoblastic Leukemia, Pediatric, run by Wei Zhao at 1 site in China.
Trial summary
The purpose of this study was to assess the efficacy and safety of individualized treatment of 6-mercaptopurine (6-MP) in Chinese children with acute lymphoblastic leukemia, and to investigate the dose-concentration-response (DER) relationship between thiopurine metabolites and adverse events. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Pediatric
- What is being tested?
- 6-mercaptopurine, Standard treatment and Individualized treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 31 Dec 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Confirmed diagnosis of acute lymphoblastic leukemia;
- Age 1-18y at time of initial diagnosis;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Informed consent signed by the patients parents or guardians before initiation of the study.
Who cannot join
- Ph-positive ALL, matrue B-cell ALL, BC-CML;
- Secondary to immunodeficiency, second cancer；
- Abnormal liver and kidney function;
- Patients divided into intermediate or high risk groups according to the risk grouping criteria of the Chinese Children Cancer Group (CCCG) protocol-ALL 2015;
- Patients who enrolled in another clinical trial;
- Expected survival time less than the treatment cycle;
- Patients with other factors that researcher considers unsuitable for inclusion
Trial locations and contacts
1 site in 1 country.
China1 site
State Key Laboratory of Experimental Haematology, Department of Paediatric Haematology, Institute of Haematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tanjin, Tianjin Municipality, 300020
About this study
The purpose of this study was to assess the efficacy and safety of individualized treatment of 6-mercaptopurine (6-MP) in Chinese children with acute lymphoblastic leukemia, and to investigate the dose-concentration-response (DER) relationship between thiopurine metabolites and adverse events. The individualized administration of 6-MP was established in Chinese children with acute lymphoblastic leukemia.
Read the detailed description
To inflict minimal pain on the child contributing blood samples, opportunistic sampling design was chosen to collect pharmacokinetic samples.
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Being tested
- 6-mercaptopurine, Standard treatment, Individualized treatment
- Keywords
- acute lymphoblastic leukemia, 6-mercaptopurine, children, individualized treatment
- 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.
6-mercaptopurineDrug
Also called 6-MP
6-mercaptopurine was administered orally to patients once daily.
Standard treatmentProcedure or surgery
The initial dose is 50mg/m2. The dose was adjusted according to white blood cells.
Individualized treatmentProcedure or surgery
The initial dose is determined according to the genotypes of patients combined with Clinical Pharmacogenetics Implementation Consortium (CPIC). The dose was adjusted according to white blood cells, genotypes and the concentrations of 6-TGN in red blood cells.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment regimen | Active comparator | 6-mercaptopurine was administered according to the Chinese Children Cancer Group (CCCG) protocol-ALL 2015. Receives: Drug: 6-mercaptopurine; Procedure: Standard treatment |
| Individualized treatment regimen | Experimental | 6-mercaptopurine was administered on the basis of Chinese Children Cancer Group (CCCG) protocol-ALL 2015 combined with Clinical Pharmacogenetics Implementation Consortium (CPIC), genotypes and the concentrations of 6-TGN in red blood cells. Receives: Drug: 6-mercaptopurine; Procedure: Individualized treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
leukopenia
Leukopenia was graded by common toxicity criteria as follows: Grade 3, 1.0-2.0 × 109/L, and Grade 4, < 1.0 × 109/L.
Measured: 6 weeks
thiopurine-induced leukopenia
Resolution of leukopenia was determined after 6-MP dose reduction or discontinuation, both in the absence of other apparent causes for the leukopenia or its disappearance.
Measured: 6-weeks
Secondary outcomes (3)
hepatotoxicity
Hepatotoxicity was defined as aspartate aminotransferase (AST) or alanine transaminase (ALT) levels 2-fold above the upper limit without cytolysis.
Measured: 6 weeks
6-thioguanine nucleotides (6-TGN) concentrations in erythrocytes.
Peripheral blood samples were obtained from steady-state plasma concentrates by opportunistic sampling design.
Measured: 3 months
6-methylmercaptopurine nucleotides (6-MMPN) concentrations in erythrocytes.
Peripheral blood samples were obtained from steady-state plasma concentrates by opportunistic sampling design.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic Leukemia, PediatricStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Zhao
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Hematology & Blood Diseases Hospital, China, Qianfoshan Hospital, Qilu Hospital of Shandong University, Children's Hospital of Hebei Province, The Affiliated Hospital of Qingdao University
- Responsible party
- Sponsor-investigator, Wei Zhao, Shandong University
- Investigators
- Wei Zhao, Ph.D, Principal investigator, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228393
- Sponsor's protocol ID
- 2020-6-mercaptopurine-001
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2020
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou Y, Wang L, Sun LR, Zhang L, Wang HM, Liu XT, Yang F, Wu KL, Liang YL, Zhao BB, Zhuang Y, Fu JQ, Song C, Li Y, Wang LZ, Xu HJ, Gu Y, van den Anker J, Ju XL, Zhu XF, Zhao W. Individualized Use of 6-Mercaptopurine in Chinese Children with ALL: A Multicenter Randomized Controlled Trial. Clin Pharmacol Ther. 2024 Feb;115(2):213-220. doi: 10.1002/cpt.3061. Epub 2023 Oct 16.
PubMed 37753808
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Individualized Treatment of 6-mercaptopurine in Children With Acute Lymphoblastic Leukemia in China
- ClinicalTrials.gov ID
- NCT04228393
- Acronym / sponsor ID
- 2020-6-mercaptopurine-001
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Keywords
- acute lymphoblastic leukemia, 6-mercaptopurine, children, individualized treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Wei ZhaoUniversity, hospital or other
- Collaborators
- Institute of Hematology & Blood Diseases Hospital, China, Qianfoshan Hospital, Qilu Hospital of Shandong University, Children's Hospital of Hebei Province, The Affiliated Hospital of Qingdao University
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 14 Jan 2020 (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.
The purpose of this study was to assess the efficacy and safety of individualized treatment of 6-mercaptopurine (6-MP) in Chinese children with acute lymphoblastic leukemia, and to investigate the dose-concentration-response (DER) relationship between thiopurine metabolites and adverse events. The individualized administration of 6-MP was established in Chinese children with acute lymphoblastic leukemia.
Detailed description
To inflict minimal pain on the child contributing blood samples, opportunistic sampling design was chosen to collect pharmacokinetic samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment regimen | Active comparator | Drug: 6-mercaptopurine, Procedure: Standard treatment6-mercaptopurine was administered according to the Chinese Children Cancer Group (CCCG) protocol-ALL 2015. |
| Individualized treatment regimen | Experimental | Drug: 6-mercaptopurine, Procedure: Individualized treatment6-mercaptopurine was administered on the basis of Chinese Children Cancer Group (CCCG) protocol-ALL 2015 combined with Clinical Pharmacogenetics Implementation Consortium (CPIC), genotypes and the concentrations of 6-TGN in red blood cells. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of acute lymphoblastic leukemia;
- Age 1-18y at time of initial diagnosis;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Informed consent signed by the patients parents or guardians before initiation of the study.
Key exclusion criteria (7 listed)
- Ph-positive ALL, matrue B-cell ALL, BC-CML;
- Secondary to immunodeficiency, second cancer；
- Abnormal liver and kidney function;
- Patients divided into intermediate or high risk groups according to the risk grouping criteria of the Chinese Children Cancer Group (CCCG) protocol-ALL 2015;
- Patients who enrolled in another clinical trial;
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 |
|---|---|---|
| 6-mercaptopurineAlso: 6-MP6-mercaptopurine was administered orally to patients once daily. | Drug | Individualized treatment regimen, Standard treatment regimen |
| Standard treatmentThe initial dose is 50mg/m2. The dose was adjusted according to white blood cells. | Procedure or surgery | Standard treatment regimen |
| Individualized treatmentThe initial dose is determined according to the genotypes of patients combined with Clinical Pharmacogenetics Implementation Consortium (CPIC). The dose was adjusted according to white blood cells, genotypes and the concentrations of 6-TGN in red blood cells. | Procedure or surgery | Individualized treatment regimen |
Primary outcome
leukopenia
Time frame: 6 weeks
Leukopenia was graded by common toxicity criteria as follows: Grade 3, 1.0-2.0 × 109/L, and Grade 4, < 1.0 × 109/L.
thiopurine-induced leukopenia
Time frame: 6-weeks
Resolution of leukopenia was determined after 6-MP dose reduction or discontinuation, both in the absence of other apparent causes for the leukopenia or its disappearance.
3 secondary outcomes
hepatotoxicity
Time frame: 6 weeks
6-thioguanine nucleotides (6-TGN) concentrations in erythrocytes.
Time frame: 3 months
6-methylmercaptopurine nucleotides (6-MMPN) concentrations in erythrocytes.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Derived from this study: PubMed 37753808Zhou Y, Wang L, Sun LR, Zhang L, Wang HM, Liu XT, Yang F, Wu KL, Liang YL, Zhao BB, Zhuang Y, Fu JQ, Song C, Li Y, Wang LZ, Xu HJ, Gu Y, van den Anker J, Ju XL, Zhu XF, Zhao W. Individualized Use of 6-Mercaptopurine in Chinese Children with ALL: A Multicenter Randomized Controlled Trial. Clin Pharmacol Ther. 2024 Feb;115(2):213-220. doi: 10.1002/cpt.3061. Epub 2023 Oct 16.
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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. This study is not recruiting at the moment.
Wei Zhao, Ph.D principal investigator
Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 6-mercaptopurine, Standard treatment and Individualized treatment in people with Acute Lymphoblastic Leukemia, Pediatric, run by Wei Zhao 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Jan 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhao, Ph.D (86053188383308, zhao4wei2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
leukopenia (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04228393, which also lists 1 linked publication.
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 14 Jan 2020.