The Children's Hospital of Zhejiang University School of Medicine
Phase
Observational
Started
2025-08-01
Last updated
2026-09-10
Condition(s) studied
Acute Lymphoblastic Leukemia, Pediatric
Study summary
The study aims to conduct a real-world investigation of children with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in China, assessing their diagnosis, treatment status, survival outcomes, and prognostic factors. The research will involve children diagnosed with Ph+ ALL between January 1, 2015, and December 31, 2024. Our objective is to understand the incidence and prognosis of CML-like ALL, compare the diagnostic and treatment differences between CML-like ALL and typical Ph+ ALL, and provide clinical evidence for standardized treatment of CML-like patients. Through a multicenter retrospective study, we hope to improve the diagnostic and treatment strategies for children with Ph+ ALL, enhancing patient survival rates and quality of life.
Eligibility
Sex
ALL
Min age
1 Month
Max age
18 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Overall Survival (OS) — From initiation of standardized treatment until death or final follow-up date, assessed up to 120 months. Overall survival (OS) is defined as the time from the initiation of standardized treatment to death from any cause, assessed up to 120 months. Patients who remain alive are censored at the date of last follow-up.
Trial sites (1)
Facility
City
Region
Status
The Children's Hospital of Zhejiang University School of Medicine
Hangzhou
Zhejiang
Recruiting
More The Children's Hospital of Zhejiang University School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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