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Optimizing Blinatumomab Access for Low- and Middle-Income Countries: Feasibility of a Shortened, Vial-Sharing,
Julia Esther Colunga Pedraza1, Andrés Gómez-De León1, Perla Rocío Colunga Pedraza1
1Hematology Department, Facultad de Medicina y Hospital Universitario Dr José Eleuterio González, Universidad Autónoma de Nuevo León, Monterrey, Mexico.
Insights
A shortened outpatient blinatumomab regimen shows promise for treating pediatric relapsed or refractory acute lymphoblastic leukemia (ALL), improving outcomes and reducing costs. This approach offers a feasible and effective strategy for heavily pretreated children.
Area of Science:
- Pediatric Oncology
- Hematology
- Immunotherapy
Background:
- Relapsed or refractory (R/R) acute lymphoblastic leukemia (ALL) in children presents significant treatment challenges.
- Blinatumomab is an effective immunotherapy, but traditional regimens can be intensive and costly.
Purpose of the Study:
- To evaluate the safety, feasibility, effectiveness, and cost-saving potential of a shortened, outpatient blinatumomab regimen.
- To assess the regimen's ability to achieve negative measurable residual disease (MRD) before hematopoietic stem-cell transplantation (HSCT) in pediatric R/R B-cell ALL (B-ALL).
Main Methods:
- Retrospective study of pediatric patients with R/R B-ALL treated with a shortened outpatient blinatumomab regimen (<21 days).
- Analysis of treatment completion, MRD status, HSCT, survival rates (OS, RFS), and drug-related expenditures.
Main Results:
- 75% of patients completed treatment entirely outpatient; 62% achieved complete remission (CR) with undetectable MRD.
- 100% of patients with persistent MRD achieved clearance; 83% proceeded to haploidentical HSCT.
- Estimated 3-year OS was 54% and RFS was 44%, with a 43% reduction in drug costs.
Conclusions:
- A reduced-duration outpatient blinatumomab regimen is a promising, context-adapted strategy for heavily pretreated pediatric ALL.
- This approach demonstrates feasibility, effectiveness, and cost-saving potential.
- Findings should be interpreted cautiously due to the small retrospective cohort size.
Purpose:
This study aims to evaluate the safety, feasibility, effectiveness, and cost-saving potential of a shortened, vial-sharing outpatient blinatumomab regimen for treating relapsed or refractory (R/R) ALL in children.
Materials And Methods:
We conducted a retrospective study of pediatric patients with R/R B-cell ALL (B-ALL) treated with a shortened outpatient blinatumomab regimen (<21 days), aiming to achieve a negative measurable residual disease (MRD) remission before hematopoietic stem-cell transplantation (HSCT).
Results:
Twelve patients were included: three (25%) with primary refractory disease and nine (75%) with relapse. The median follow-up time was 33 months (range, 10-76 months). Blinatumomab was administered for a median of 19 days (range, 11-21), with 75% (9 of 12) of patients completing treatment entirely on an outpatient basis. Five patients (62%) achieved CR with undetectable MRD, and all four patients who initiated treatment because of persistent MRD achieved MRD clearance (100%). Ten patients (83%) proceeded to haploidentical HSCT. The estimated 3-year overall survival (OS) was 54%, and the relapse-free survival (RFS) was 44%. These optimization measures resulted in a 43% reduction in drug-related expenditures.
Conclusion:
Reduced-duration outpatient blinatumomab shows promise as a context-adapted strategy for heavily pretreated pediatric patients with ALL. Given the small retrospective cohort, these findings should be interpreted with caution.
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