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Observational Study of Minimal Residual Disease (MRD)-Guided Therapy Based on IgH V(D)J Next-Generation Sequencing (NGS) Measurement in B-Cell Acute Lymphoblastic Leukemia

Observational Study of Minimal Residual Disease (MRD)-Guided Therapy Based on IgH V(D)J Next-Generation Sequencing (NGS) Measurement in B-Cell Acute Lymphoblastic Leukemia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123471
Enrollment
Unknown
Registered
2026-04-27
Start date
2025-11-12
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-acute lymphoblastic leukemia

Interventions

Treatment-naive B-ALL:None

Sponsors

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=14 years old, treatment-naive B-ALL. 2.Abnormal clones were detected through IgH NGS during the initial bone marrow puncture examination. 3.Patients without severe organ dysfunction and chemotherapy-tolerable. 4.atients participated voluntarily.

Exclusion criteria

Exclusion criteria: 1.Patients treated with chemotherapy previously. 2.Patients who can not be treated after being evaluated by the clinical physicians, due to other malignant tumors, infections and so on. 3.Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
IgH next-generation sequencing;3-year disease-free survival rate and disease-free survival rate (RFS);

Secondary

MeasureTime frame
The negative conversion rate of MRD by IgH next-generation sequencing after treatment;Overall survival time;The occurrence of treatment-related adverse reaction events;Transplantation rate and survival rate after transplantation;

Countries

China

Contacts

Public ContactHuang Wei

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology

2896607051@qq.com+86 713 7339270

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026