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

NCT07813208 | Recruiting

• 1 other identifier: 2025-IRB-0385-P-01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Keywords

Acute Lymphoblastic Leukemia

Outcome Measures

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.

  From initiation of standardized treatment until death or final follow-up date, assessed up to 120 months.

Secondary Outcomes (1)

• Event-Free Survival (EFS)

  From initiation of standardized treatment until first event or final follow-up date, assessed up to 120 months.

Study Arms (2)

Typical Ph+ ALL cohort

Patients with pediatric Philadelphia chromosome-positive ALL without CML-like features.

CML-like Ph+ ALL cohort

Pediatric Ph+ ALL patients with CML-like biological features.

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Aimei Ma

CONTACT

+86-571-86670076; zuchiec@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 10, 2026
• Study Start: August 1, 2025
• Primary Completion: September 1, 2026
• Study Completion: September 1, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)