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Recruiting NCT07813208

Ph+ ALL in Chinese Children: Diagnosis, Treatment, and Survival

Conditions: Acute Lymphoblastic Leukemia, Pediatric

Sex: All
Ages: 1 Month – 18 Years
Healthy volunteers: No
Enrollment: 500
Sponsor: The Children's Hospital of Zhejiang University School of Medicine

Location: The Children's Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang

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 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07813208). StuddyBuddy aggregates publicly available trial information.