Skip to content

Pharmacovigilance Analysis of Belimumab in Children Based on Clinical Practice Combined with FAERS Database

Pharmacovigilance Analysis of Belimumab in Children Based on Clinical Practice Combined with FAERS Database

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113159
Enrollment
Unknown
Registered
2025-11-25
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Acute lymphoblastic leukemia

Interventions

Acute lymphoblastic leukemia children under 18 years of age treated with belimumab:None

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 17 Years

Inclusion criteria

Inclusion criteria: 1.Age between 28 days and 18 years, with no gender restrictions; 2.Refractory response to initial chemotherapy, characterized by an inability to continue due to severe complications during the standard induction remission protocol or consolidation therapy, or a suboptimal response to chemotherapy, indicated by minimal residual disease (MRD) levels of >=0.01% as determined by flow cytometry, PCR, or next-generation sequencing after two standard induction cycles; 3.Progression to the maintenance phase or bridge transplantation; 4.Relapsed B-cell acute lymphoblastic leukemia (B-ALL), defined by>=5% bone marrow involvement post-complete remission or extramedullary relapse; 5.Recurrence of MRD, indicated by MRD levels of =0.01% reoccurring after achieving <0.01% on standard treatment.

Exclusion criteria

Exclusion criteria: 1.Pediatric patients presenting with extramedullary recurrence confined solely to the central nervous system; 2.Individuals who did not undergo bone marrow evaluation both prior to and following belimumab therapy; 3.Patients who failed to complete the prescribed course of treatment due to various reasons; 4.Patients who did not undergo assessments for cytokines, liver function, and other relevant tests during the course of belimumab treatment.

Design outcomes

Primary

MeasureTime frame
Adverse reaction;

Countries

China

Contacts

Public ContactTu Yingqiu

The First Affiliated Hospital of Nanchang University

798783079@qq.com+86 791 88692733

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026