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

NCT07813208

RecruitingN/A

Sponsor: The Children's Hospital of Zhejiang University School of Medicine

Conditions: Acute Lymphoblastic Leukemia, Pediatric

Countries: China

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 overview

Sex: ALL

Age: 1 Month to 18 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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.
Locations (1)
  • Hangzhou, Zhejiang, China