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.
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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.
Reference
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