First-in-World Subcutaneous Blincyto Trial Opens for Leukemia at WVU

Dr. Ashkan Emadi, principal investigator of a first-in-world phase 2 clinical trial evaluating subcutaneous Blincyto (blinatumomab) for CD19-positive mixed phenotype acute leukemia, sat down for an interview with CURE.

Emadi discussed what the trial, which is being conducted at the WVU Cancer Institute, means for patients and who may be eligible to participate. The investigator-initiated trial is the first to examine a subcutaneous formulation of the CD19-directed bispecific T-cell engager in this ultra-rare and aggressive leukemia, a disease with no established standard of care and historically poor outcomes. The study includes cohorts for newly diagnosed patients who are not candidates for intensive chemotherapy, patients in morphologic complete remission with measurable residual disease positivity, and those with relapsed or refractory disease.

In this conversation, Emadi explains how patients can be referred, what the screening and enrollment process involves, and what to expect during the initial inpatient monitoring period and subsequent outpatient treatment.

Emadi is chair of the Department of Medical Oncology; Alexander Bland Osborn Endowed Chair and distinguished professor of Medical Oncology; physician-in-chief of Medical Oncology; and associate director for Clinical Research at WVU Cancer Institute.

Transcript

Clinical trials can feel intimidating, especially for people with limited options. What should patients with newly diagnosed, measurable residual disease–positive or relapsed disease know about who may be eligible for the study and what participation could involve?

Currently, this study is only open at West Virginia University. Here in Morgantown, we have a very robust cancer center and a lot of hotel and lodging options for people who are willing to come here. It is not only for newly diagnosed patients; it is also for people in complete remission with minimal residual disease positivity and for relapsed refractory disease, as long as they have CD19-positive disease.

[On our website], we have a direct phone number and an email. People can contact that number or send that email and forward their pathology or their local doctor’s number. It comes to our Clinical Research Unit, where a very professional research coordinator and clinical nurse coordinator review the patient’s data. Each clinical trial has inclusion and exclusion criteria.

People must meet all of the inclusion criteria and none of the exclusion criteria. If people are eligible, they will be contacted and told when they can come in, and then they are scheduled to see me or one of my leukemia colleagues here at WVU. We evaluate the patient. As of right now, per FDA mandate, people have to be inpatient for the first seven days at the lower dose. After discharge, we help with family housing or a local hotel at a very discounted rate based on the patient’s budget. Sometimes it can be free, and sometimes a patient’s insurance can provide that support.

The drug itself is completely free of charge. That is the current status. Very soon, we will have the study open in two or three other states, mainly on the East Coast and hopefully the Midwest. When those studies open at other institutions, people who live closer to those centers can go there. I know those colleagues personally; they are outstanding leukemia doctors at very reputable, National Cancer Institute–designated comprehensive cancer centers, so people can feel very comfortable being treated by my colleagues at those other centers when they open.

Transcript has been edited for clarity and conciseness.

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