Childhood Acute Lymphoblastic LeukemiaNCT07462299
NUDT15/TPMT Multi-gene Guided 6-MP Dosing in Childhood ALL Maintenance Therapy
A study testing NUDT15/TPMT genotype-guided 6-MP dosing in people with Childhood Acute Lymphoblastic Leukemia, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
This is a prospective, single-center clinical study to evaluate the safety and efficacy of a personalized 6-mercaptopurine (6-MP) dosing strategy guided by NUDT15 and TPMT genotypes in children with Acute Lymphoblastic Leukemia (ALL) during maintenance therapy. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Childhood Acute Lymphoblastic Leukemia
- What is being tested?
- NUDT15/TPMT genotype-guided 6-MP dosing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2026to 31 Dec 2028
- Phase
- Interventional
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with ALL and scheduled for maintenance therapy. Plan to receive oral 6-MP. NUDT15 and TPMT genotyping results available. Baseline liver and kidney function within acceptable limits (ALT/AST ≤ 2.5xULN, etc.).
- Signed informed consent. -
Who cannot join
- Down syndrome. Relapsed/refractory disease before maintenance. Prior hematopoietic stem cell transplantation. Severe organ dysfunction or uncontrolled infection.
- -
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
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Tian Xia, PhD, 86-15267035696, xiatiansky2013@163.com
About this study
Official title: A Prospective Study of NUDT15/TPMT Multi-gene Combined Guidance on 6-MP Dosage During Maintenance Therapy in Childhood Acute Lymphoblastic Leukemia
This is a prospective, single-center clinical study to evaluate the safety and efficacy of a personalized 6-mercaptopurine (6-MP) dosing strategy guided by NUDT15 and TPMT genotypes in children with Acute Lymphoblastic Leukemia (ALL) during maintenance therapy. The study compares this gene-guided strategy with historical controls to assess if it reduces the incidence of Grade ≥3 neutropenia and infection events.
- Conditions
- Childhood Acute Lymphoblastic Leukemia
- Being tested
- NUDT15/TPMT genotype-guided 6-MP dosing
- Keywords
- NUDT15, TPMT, 6-MP, Pharmacogenetics, Maintenance Therapy
- 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.
NUDT15/TPMT genotype-guided 6-MP dosingDrug
Initial dosage of 6-Mercaptopurine (6-MP) is stratified based on NUDT15 and TPMT genotypes:
Normal metabolizers: 100% standard dose (50-75 mg/m^2/d). Intermediate metabolizers: 30-80% of the recommended dose. Poor metabolizers: 10-30% of the recommended dose. Subsequent dosage adjustments are made based on toxicity monitoring and therapeutic drug monitoring (TDM) of 6-TGN and 6-MMP levels.
| Study group | Role | What they receive |
|---|---|---|
| Genotype-guided Dosing Group | Experimental | All participants will receive 6-MP maintenance therapy with dosage adjustments based on their NUDT15 and TPMT genotype status. Receives: Drug: NUDT15/TPMT genotype-guided 6-MP dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence of Grade 3 or Higher Neutropenia
Defined according to NCI CTCAE v5.0 criteria. Grade ≥3 neutropenia is defined as an Absolute Neutrophil Count (ANC) < 1000/mm³. The measure reports the percentage of participants who experience at least one episode of Grade ≥3 neutropenia.
Measured: From the start of maintenance therapy up to Month 12
Secondary outcomes (2)
Incidence of Severe Infection and Febrile Neutropenia (FN)
The percentage of participants experiencing Grade 3 or higher infections (assessed per NCI CTCAE v5.0) or FN events. FN is defined as a single oral temperature ≥38.3°C or ≥38.0°C sustained for more than 1 hour, combined with an ANC < 500/mm³.
Measured: Up to 12 months from the start of maintenance therapy
Relative Dose Intensity (RDI) of 6-Mercaptopurine (6-MP)
RDI is calculated as the ratio of the actual cumulative dose of 6-MP received by the participant to the recommended cumulative dose based on the standard protocol (calculated by body surface area). The result is reported as a percentage.
Measured: Up to 12 months from the start of maintenance therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start20 Feb 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University
- Responsible party
- Principal investigator, xiatian, The Children's Hospital of Zhejiang University School of Medicine
- Investigators
- Tian Xia, MD, Principal investigator, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462299
- Sponsor's protocol ID
- 2026-IRB-0015-P-01
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of NUDT15/TPMT Multi-gene Combined Guidance on 6-MP Dosage During Maintenance Therapy in Childhood Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07462299
- Acronym / sponsor ID
- 2026-IRB-0015-P-01
- Conditions
- Childhood Acute Lymphoblastic Leukemia
- Keywords
- NUDT15, TPMT, 6-MP, Pharmacogenetics, Maintenance Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Collaborators
- Zhejiang University
- Study start
- 20 Feb 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Mar 2026 (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.
This is a prospective, single-center clinical study to evaluate the safety and efficacy of a personalized 6-mercaptopurine (6-MP) dosing strategy guided by NUDT15 and TPMT genotypes in children with Acute Lymphoblastic Leukemia (ALL) during maintenance therapy. The study compares this gene-guided strategy with historical controls to assess if it reduces the incidence of Grade ≥3 neutropenia and infection events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genotype-guided Dosing Group | Experimental | Drug: NUDT15/TPMT genotype-guided 6-MP dosingAll participants will receive 6-MP maintenance therapy with dosage adjustments based on their NUDT15 and TPMT genotype status. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosed with ALL and scheduled for maintenance therapy. Plan to receive oral 6-MP. NUDT15 and TPMT genotyping results available. Baseline liver and kidney function within acceptable limits (ALT/AST ≤ 2.5xULN, etc.).
- Signed informed consent. -
Key exclusion criteria (2 listed)
- Down syndrome. Relapsed/refractory disease before maintenance. Prior hematopoietic stem cell transplantation. Severe organ dysfunction or uncontrolled infection.
- -
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 |
|---|---|---|
| NUDT15/TPMT genotype-guided 6-MP dosingInitial dosage of 6-Mercaptopurine (6-MP) is stratified based on NUDT15 and TPMT genotypes: Normal metabolizers: 100% standard dose (50-75 mg/m^2/d). Intermediate metabolizers: 30-80% of the recommended dose. Poor metabolizers: 10-30% of the recommended dose. Subsequent dosage adjustments are made based on toxicity monitoring and therapeutic drug monitoring (TDM) of 6-TGN and 6-MMP levels. | Drug | Genotype-guided Dosing Group |
Primary outcome
Cumulative Incidence of Grade 3 or Higher Neutropenia
Time frame: From the start of maintenance therapy up to Month 12
Defined according to NCI CTCAE v5.0 criteria. Grade ≥3 neutropenia is defined as an Absolute Neutrophil Count (ANC) < 1000/mm³. The measure reports the percentage of participants who experience at least one episode of Grade ≥3 neutropenia.
2 secondary outcomes
Incidence of Severe Infection and Febrile Neutropenia (FN)
Time frame: Up to 12 months from the start of maintenance therapy
Relative Dose Intensity (RDI) of 6-Mercaptopurine (6-MP)
Time frame: Up to 12 months from the start of maintenance therapy
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 10 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Tian Xia, MD principal investigator
The Children's Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUDT15/TPMT genotype-guided 6-MP dosing in people with Childhood Acute Lymphoblastic Leukemia, run by The Children's Hospital of Zhejiang University School of Medicine 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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 10 Mar 2026. 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.
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 tian xia, MD (+86 15267035696, xiatiansky2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence of Grade 3 or Higher Neutropenia (time frame: From the start of maintenance therapy up to Month 12). 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 10 Mar 2026.