1. ALL-071: 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)
- Author
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Krishna Gundabolu, Deepa Jeyakumar, Faraz Zaman, Michael Kenneth Keng, Paul Gordon, Kristen M. O'Dwyer, Hemant S. Murthy, Caspian Oliai, Gerhard Zugmaier, Shahram Mori, Christopher McCann, Timothy S. Pardee, Tulio E. Rodriguez, Sharif S. Khan, Michal Bar-Natan, and Anthony S. Stein
- Subjects
Cancer Research ,medicine.medical_specialty ,Hotline ,business.industry ,Vital signs ,Context (language use) ,Hematology ,Disease ,medicine.disease ,Cytokine release syndrome ,Blood pressure ,Oncology ,Emergency medicine ,medicine ,Blinatumomab ,business ,Adverse effect ,medicine.drug - Abstract
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.
- Published
- 2021
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