|The following article features coverage from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Click here to read more of Hematology Advisor‘s conference coverage.|
A phase 4 trial, the details of which were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, is evaluating the safety and effectiveness of at-home blinatumomab treatment among patients with minimal residual disease (MRD)-positive B cell precursor acute lymphoblastic leukemia (BCP-ALL).
Patients with BCP-ALL tend to have a poor prognosis, and MRD-positivity is a strong prognostic indicator in this patient population. Blinatumomab is a CD3/CD19-targeting drug that has previously been shown to be effective among patients with MRD-positive disease. The study being presented at ASCO (ClinicalTrials.gov Identifier: NCT04506086) is a phase 4 feasibility trial of at-home blinatumomab among patients with BCP-ALL.
A total of 45 patients with BCP-ALL who are in complete remission with MRD-positive disease are being enrolled. All patients will receive blinatumomab as a continuous infusion for 2 to 4 cycles consisting of 28 days. As patients are normally hospitalized for the initial phases of cycles 1 and 2 to watch for adverse events, at-home monitoring will be evaluated as an alternative.
Patients will set up a home hub device for continuous monitoring during at-home treatment. The home hub device will involve consistent availability of a healthcare professional, who can communicate with the patient and make recommendations and adjustments as needed.
The trial is intended to evaluate the feasibility of this novel at-home treatment of blinatumomab in this patient population.
Disclosure: The study author(s) declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Read more of Hematology Advisor’s coverage of the 2021 ASCO Annual Meeting by visiting the conference page.
Khan SS, Mori S, Jeyakumar D, et al. 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). J Clin Oncol. 2021;39:(suppl 15; abstr TPS7051). doi:10.1200/JCO.2021.39.15_suppl.TPS7051