Ph+ ALL in Chinese Children: Diagnosis, Treatment, and Survival
Official title: Real-world Investigation of Diagnosis, Treatment, and Survival Status of Children With Ph+ ALL in China
Run by The Children's Hospital of Zhejiang University School of Medicine · NCT07813208 · Data updated 2026-11-12
This study tests how children in China with Philadelphia chromosome–positive ALL are diagnosed, treated, and how long they survive in real-world practice.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Month to 18 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | The Children's Hospital of Zhejiang University School of Medicine Academic / other |
| Drugs / interventions | imatinib, dasatinib, chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | September 2026 |
| Study ends | September 2026 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT07813208 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children diagnosed with Ph+ ALL between 2015 and 2024 who had serial MRD testing and received standardized TKI therapy.
✕Probably not a fit
Patients without serial MRD data or those not treated with standardized TKIs may not derive the study's intended insights.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a national multicenter retrospective study that reviews medical records of children diagnosed with Ph+ ALL in China from 2015 to 2024. It compares CML-like ALL to typical Ph+ ALL in terms of diagnosis, treatment, and outcomes, with a focus on MRD monitoring and the use of TKIs. The analysis aims to identify prognostic factors and inform standardized treatment strategies to improve survival and quality of life. Data will include MRD results from flow cytometry and molecular testing, treatment regimens, and survival outcomes. Results will reflect real-world practice rather than a controlled trial setting.
Why it matters
Potential benefit: If successful, findings could standardize diagnostic and treatment approaches for pediatric Ph+ ALL in China and potentially improve survival rates.
How similar studies have gone: Previous reports show improved outcomes with TKIs in Ph+ ALL, though real-world patterns and CML-like ALL subtypes require further clarification.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age at diagnosis ranging from 1 month to 18 years. 2. Positive for the BCR::ABL fusion gene. 3. Serial quantitative MRD testing was routinely performed using multiparameter flow cytometry (MFC) and PCR (qRT-PCR or ddPCR) during treatment, with samples collected for both assays at identical time points. 4. Standardized TKI therapy (imatinib, dasatinib, or other TKIs) was administered. Exclusion Criteria: 1. Mixed-phenotype acute leukemia. 2. Irregular treatment not administered in accordance with the chemotherapy protocol. 3. Previous or concurrent other malignancies. 4. Failure to receive standardized TKI therapy due to intolerance to TKIs, contraindications to TKI treatment, or other relevant factors.
Where it's running
-
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Aimei Ma
- Email: zuchiec@163.com
- Phone: +86-571-86670076
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.