A Phase 4 Study To Evaluate Outpatient Blinatumomab In Patients With Minimal/Measurable Residual Disease (Mrd) Positivity (+) Of B-Cell Precursor Acute Lymphoblastic Leukemia (Bcp-All)

Context/Objective: Blinatumomab, a CD3/CD19-directed BiTE® (bispecific T-cell engager) molecule, is an effective treatment for patients with MRD+ BCP-ALL.1 Blinatumomab is infused continuously (cIV) 28 days/cycle. Severe adverse events (AEs), e.g., cytokine release syndrome (CRS) and neurologic toxicity (NT), may occur; thus, hospitalization is recommended for cycle 1: days 1–3 (C1:D1–3) and C2:D1–2. However, the incidence of severe AEs is low (CRS: 2%, NT: 13%).1 We believe that with digital monitoring, blinatumomab can be safely administered as an outpatient. Design: Adult patients (n=45) with BCP-ALL in complete remission and MRD+ (≥0.1% blasts) are being enrolled at ≤25 sites, with endpoint: grade ≥3 AE (Amgen NCT04506086). Patient suitability and outpatient monitoring are established. Patients receive 2–4 blinatumomab cycles. Cycles are initiated in the outpatient setting, and digital monitoring devices are activated/attached. Once home, patients set up the home hub and real-time data transfer to the healthcare provider (HCP) begins. The devices are worn continuously, 24 hours/day, for C1:D1–3 and C2:D1–2 only. Devices: Current Health’s Wearable Monitoring System (CHWMS) is an FDA-cleared platform for wireless wearable health monitoring at home. The CHWMS provides continuous oxygen saturation, respiratory rates, and heart rates; an axillary sensor provides continuous temperature. Patients manually measure blood pressure every 3–6 hours around the clock. Patients have an integrated tablet to contact the HCP if needed. HCP/designee has a smartphone and receives vital signs constantly. The CHWMS platform generates a loud alert based on pre-specified vital sign thresholds or for data transfer interruption. Regardless of whether there is an alert, HCP may initiate direct audio/video contact with the patient, assess the patient’s condition, and make appropriate interventions. Patients are required to have a caregiver present during monitoring. Patients have a full set of replacement devices and a 24/7 support hotline. Trial enrollment is underway. This study may generate feasibility data on the effectiveness of home monitoring during blinatumomab infusion in patients with MRD+ BCP-ALL. 1Gokbuget, Blood, 2018. © 2021 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2021 ASCO Annual Meeting. All rights reserved.