Study on blinatumomab administered as a subcutaneous injection rather than as an infusion via a venous access site in patients with relapsed acute lymphoblastic leukemia (ALL)

Acute lymphoblastic leukemia (ALL) is a type of cancer that affects lymphocytes, a type of white blood cell. The bone marrow produces an excessive number of immature lymphocytes, which displace normal blood cells and weaken the immune system. The disease progresses rapidly and therefore requires immediate treatment. The standard treatment for ALL consists of intensive chemotherapy, sometimes followed by a stem cell transplant. If patients do not respond to treatment or the disease returns, blinatumomab may be used. This is a bispecific antibody that specifically binds to cancer cells and stimulates the immune system to destroy them. Blinatumomab is typically administered as a continuous intravenous infusion. In this study, blinatumomab is administered under the skin (subcutaneously), which makes administration easier and potentially less burdensome.

The goal of this Phase 1/2 study is to investigate the efficacy and safety of this method of administering blinatumomab in patients with refractory or relapsed ALL. The study consists of several phases: In the first phase, the dose-escalation phase, patients receive different doses of blinatumomab to determine the maximum tolerated dose (MTD)—that is, the dose without limiting side effects. To this end, adverse events and disease-related events will be recorded for up to 28 weeks after the start of the study. The dose-expansion phase (Phase 2) is designed to evaluate safety and efficacy by treating patients with the determined dose. Patients are assigned to up to 4 cohorts (non-randomly). The assignment is known to both the patients and the medical staff (open-label). In the final phase (Phase 2c), the pharmacokinetic properties of the drug (how the body absorbs, distributes, metabolizes, and excretes the drug) will be compared for two blinatumomab formulations. In total, participants will be monitored for up to 28 weeks per phase.

Eligible participants include women and men aged 18 and older, as well as—in certain cohorts—adolescents aged 12 and older with acute lymphoblastic leukemia that has recurred or is refractory to treatment.