T-cell acute lymphoblastic leukemia (T-cell ALL) is a fast-growing blood cancer that starts in the bone marrow and affects T-cells. T-cells are a type of white blood cell involved in the body's immune system. The body needs healthy T-cells to fight infections and disease. With T-cell ALL, abnormal T-cells crowd out healthy cells, weakening the immune system. The word 'acute' means that the disease progresses quickly and can be severe (Leukemia Research Foundation).
The usual treatment for patients with T-cell ALL is chemotherapy and possibly a stem cell transplant—also known as a bone marrow transplant. This procedure replaces bone marrow with healthy cells, either from a patient's own body or from a donor. However, despite these treatments, in many cases, leukemia will remain at a very low level in the body. Patients with this condition have a higher risk of relapse—and no standard of care treatment options.
Researchers at the ECOG-ACRIN Cancer Research Group are seeking better options for patients with T-cell ALL that is detected at a very low level in the body following initial treatment. Recently, the FDA approved a drug (daratumumab-hyaluronidase) for use alone or with other medications to treat patients with multiple myeloma and one other blood disease. There is early evidence that this drug may effectively get rid of the remaining disease for patients with T-cell ALL. The EA9213 clinical trial aims to find out.
Daratumumab works by stimulating the body's immune system to destroy cancer cells. The form being used in this trial is an injection under the skin of the abdomen that takes only three to five minutes.
Patients with T-cell ALL are eligible for this study if they are in remission after a minimum of two cycles of chemotherapy, and testing shows disease at a very low level. Patients may have undergone a prior stem cell transplant, but may not have graft-versus-host disease that requires ongoing treatment.
All patients who enroll in EA9213 will receive the study drug once weekly for four doses. After this treatment, patients will have a bone marrow biopsy to see if the disease is still present. If no disease, they will receive an additional four weekly doses of the study drug or proceed to a stem cell transplant under their doctor's advice. Patients with remaining disease will receive an additional four weekly doses of the study drug plus chemotherapy.
Patients who complete a second four-week course of study drug will need to undergo another bone marrow biopsy. If no remaining disease at this point, they may receive additional study drug or proceed to a stem cell transplant as recommended by their doctor. If there is still disease at this point, patients will go off study.
This study is led by Shira Dinner, MD of Northwestern University.
Learn more about EA9213 at ecog-acrin.org.