About this study
Some patients with B-cell acute lymphoblastic leukemia (B-ALL) do not get better with standard treatment. This is called refractory disease. In some people, the cancer comes back after treatment. This is called relapse. Others have a small number of leukemia cells left after treatment. This is called minimal residual disease, or MRD. B-ALL that comes back or does not go away can be hard-to-treat. Doctors are looking for new ways to help these patients live longer and have fewer problems from their cancer.
This study tests a medicine called blinatumomab. Blinatumomab is a type of immunotherapy that helps the body’s immune system find and attack leukemia cells. Doctors already use this medicine to treat some people with B-ALL. In this study, researchers are testing a new way to give the medicine. Instead of giving it through a vein with an IV, they give it as a shot under the skin.
This trial has 2 parts. In the first part, small groups of patients get the medicine. Researchers slowly raise the dose to find the safest amount. They also watch closely for side effects. In the second part, more patients get the medicine at the safest high dose. This helps researchers see how well the treatment works.
Researchers watch how patients respond to treatment. They check if the leukemia goes away or becomes too small to find. They also study side effects and how the medicine moves through the body.
This study may help doctors find out if blinatumomab given as a shot under the skin is safe and helpful for patients age 12 years and older with hard-to-treat B-ALL. This study will help doctors learn more about how to treat this disease.
Eligibility overview
- Age 12 years and older
- B‑cell precursor acute lymphoblastic leukemia that is relapsed, refractory, or minimal residual disease–positive
- Leukemia cells express CD19
- Disease present in the bone marrow