Blinatumomab Care Delivery for Pediatric B-Cell Acute Lymphoblastic Leukemia.

Abstract

Blinatumomab, a novel immunotherapy administered as a 28-day continuous infusion, has fundamentally shifted the treatment paradigm for pediatric B-cell acute lymphoblastic leukemia (B-ALL) and is now considered a component of standard therapy for the most common childhood cancer. However, the care delivery challenges in transitioning from an experimental agent on a clinical trial to widespread clinical implementation are unknown. To characterize the clinical landscape of pediatric blinatumomab care-delivery practice and challenges in the US from the perspective of treating centers. This survey study was conducted from February to March 2025 among US member institutions of the Children's Oncology Group (COG) across 44 states. Institutional characteristics, including participation in the National Cancer Institute Community Oncology Research Program (NCORP), US census region, site-reported annual pediatric ALL patient volume, and prior blinatumomab experience, were assessed. Incorporation of blinatumomab as standard therapy by pediatric B-ALL subtype; major outpatient care-delivery challenges defined as 4 or 5 on a 5-point Likert scale by more than 25% of centers. Of 195 active US COG member institutions, 147 centers completed the survey and were successfully matched with a unique COG identifier, among which 35 institutions (23.8%) were NCORP participants. There were 32 institutions (21.8%) in Midwest, 30 institutions (20.4%) in Northeast, 60 institutions (40.8%) in South, and 25 institutions (17.0%) in West census regions. Most centers reported using blinatumomab as their institutional standard therapy for National Cancer Institute standard risk-average (134 centers [91.2%]), standard risk-high (144 centers [98.0%]), and high-risk (140 centers [95.2%]) B-ALL. Fewer centers reported using blinatumomab for infant (83 centers [56.5%]) or Philadelphia chromosome-positive (96 centers [65.3%]) B-ALL. The most common major outpatient blinatumomab site care-delivery challenges included lack of home care companies (75 centers [51.0%]), family distance to treating center (41 centers [27.9%]), and insurance coverage for home care companies (37 centers [25.2%]). There were 67 sites (45.6%) that reported having no home care company options for any patients. In this study, challenges associated with pediatric blinatumomab home care were highly prevalent, with broader implications for health system infrastructure availability. These data highlight a need to plan for clinical implementation strategies alongside the development and testing of novel therapies.