Ph+ ALL in Chinese Children: Diagnosis, Treatment, and Survival
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorThe Children's Hospital of Zhejiang University School of Medicine
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age at diagnosis ranging from 1 month to 18 years.
Positive for the BCR::ABL fusion gene.
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.
Standardized TKI therapy (imatinib, dasatinib, or other TKIs) was administered.
Disqualifiers
Mixed-phenotype acute leukemia.
Irregular treatment not administered in accordance with the chemotherapy protocol.
Previous or concurrent other malignancies.
Failure to receive standardized TKI therapy due to intolerance to TKIs, contraindications to TKI treatment, or other relevant factors.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 2 trial groupsGroup A: Typical Ph+ ALL cohort
Group B: CML-like Ph+ ALL cohort
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov