Clinical trial · Observational
Ph+ ALL in Chinese Children: Diagnosis, Treatment, and Survival
Real-world Investigation of Diagnosis, Treatment, and Survival Status of Children With Ph+ ALL in China
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia, Pediatric | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Typical Ph+ ALL cohort
- description
- Patients with pediatric Philadelphia chromosome-positive ALL without CML-like features.
- label
- CML-like Ph+ ALL cohort
- description
- Pediatric Ph+ ALL patients with CML-like biological features.
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- From initiation of standardized treatment until death or final follow-up date, assessed up to 120 months.
- description
- 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.
Secondary outcomes (1)
- measure
- Event-Free Survival (EFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available