An observational study in Acute Lymphoblastic Leukemia, Pediatric, sponsored by The Children's Hospital of Zhejiang University School of Medicine. Recruiting at 1 site in China. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by The Children's Hospital of Zhejiang University School of Medicine · Observational
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.
This is a national multicenter retrospective real-world study, aiming to investigate the diagnosis, treatment, and survival status of pediatric Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in China. Ph+ ALL accounts for 3%-5% of all childhood ALL cases and was historically associated with poor prognosis. The widespread clinical application of tyrosine kinase inhibitors (TKIs) has significantly improved the overall survival (OS) of pediatric Ph+ ALL, with current OS rates reaching 70%-80%, and most patients no longer require hematopoietic stem cell transplantation (HSCT).
Minimal residual disease (MRD) monitoring is the core indicator for evaluating treatment efficacy and prognosis of Ph+ ALL. Common clinical MRD detection methods include multiparameter flow cytometry (MFC), quantitative polymerase chain reaction (qPCR) targeting BCR-ABL1 fusion gene and immunoglobulin/T-cell receptor (Ig/TR) gene rearrangement, and next-generation sequencing (NGS). However, prominent inconsistent MRD results across different detection methods are frequently observed during clinical follow-up. A specific subtype termed CML-like ALL has been defined, in which BCR::ABL fusion genes are detected not only in leukemic lymphoblasts but also in non-leukemic myeloid and lymphoid cells. Distinct from typical Ph+ ALL, the MRD level of CML-like ALL lacks prognostic predictive value, and such patients are prone to treatment-related mortality rather than disease relapse, leading to potential overtreatment.
Existing overseas and domestic studies have confirmed the clinical heterogeneity between CML-like ALL and typical Ph+ ALL, but large-sample real-world data focusing on Chinese pediatric populations remain insufficient. This study retrospectively enrolls pediatric Ph+ ALL patients newly diagnosed between January 1, 2015, and December 31, 2024. from multiple Chinese medical centers. All enrolled children received standardized TKI therapy and simultaneous paired MRD detection via MFC and PCR at consistent time points. Patients are stratified into CML-like ALL and typical Ph+ ALL groups.
The primary study outcomes include national real-world survival data (OS, event-free survival [EFS]) of pediatric Ph+ ALL, the incidence and clinical characteristics of CML-like ALL, and the differences in diagnosis, treatment, MRD dynamic changes, and prognosis between the two subtypes. This study adopts standardized real-world data collection and rigorous statistical analysis, with a target enrollment of over 500 patients to ensure statistical validity. This retrospective study involves no additional clinical intervention or increased medical risks for patients, with all data fully desensitized to protect privacy. The findings will supplement Chinese clinical evidence for individualized risk stratification and precise treatment of pediatric Ph+ ALL, optimize overtreatment status of CML-like ALL, and improve long-term survival outcomes of affected children.
2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.
This study's planned enrollment of 500 is above the median of 108 across 400 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →The Children's Hospital of Zhejiang University School of Medicine is the lead sponsor of 69 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population included pediatric patients aged 1 month to 18 years with newly diagnosed Ph+ ALL from multiple centers diagnosed between 2015 and 2024.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with pediatric Philadelphia chromosome-positive ALL without CML-like features.
Pediatric Ph+ ALL patients with CML-like biological features.
Overall Survival (OS)
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.
Time frame: From initiation of standardized treatment until death or final follow-up date, assessed up to 120 months.
Event-Free Survival (EFS)
Event-free survival (EFS) is defined as the time from the initiation of standardized treatment to the first event, assessed up to 120 months. Patients without events are censored at the last follow-up. EFS will be compared between two cohorts.
Time frame: From initiation of standardized treatment until first event or final follow-up date, assessed up to 120 months.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Precursor Cell Lymphoblastic Leukemia-Lymphoma →
The Children's Hospital of Zhejiang University School of Medicine