This study is looking for patients with relapsed or unresponsive chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) to test IOV-2001, a treatment that boosts cancer-killing immune cells. The main outcome that will be measured is how well patients respond to treatment. This study is recruiting in Columbus, OH, the US.
Leukemia and lymphoma are cancer of immune cells. Often lymphoma cells are able to stop healthy immune cells that kill cancer from growing. After initial treatment, the cancer may come back (relapse) or become refractory (stop responding to treatment).
In IOV-2001 treatment, patients’ healthy immune cells are taken from blood and stimulated with IOV-2001. This activates them and allows them to grow rapidly. These cells are injected back into the patient with another drug called IL-2. IL-2 encourages the cells to continue growing in the patient so that they fight the cancer.
This study is looking for patients with relapsed or refractory CLL or SLL to test IOV-2001. The main measurement of this study will be how strongly patients respond to IOV-2001.
Who are they looking for?
This study is recruiting 70 patients with relapsed or refractory CLL or SLL. Patients must have tumors that can be measured. Patients must be currently receiving ibrutinib (Imbruvica) treatment and have had another treatment. Patients’ life expectancy should be more than 3 months. Patients must have healthy bone marrow, lung and heart function. Patients of childbearing age must be willing to use birth control during the trial and for 12 months after the last dose.
Patients who received an organ or stem cell transplant in the last 20 years cannot participate. Patients who received any treatment for leukemia (except ibrutinib) 30 days before the trial starts cannot participate. Patients with cancer in the brain cannot participate. Patients with certain infections, including HIV and Hepatitis B and C, cannot participate. Patients receiving anti-coagulation or long-term steroid medication cannot participate. Patients who are pregnant or breastfeeding cannot participate.
How will it work
Patients will be divided into two groups. The first group will receive IOV-2001 and a low dose of IL-2. The second group will receive IOV-2001 and a high dose of IL-2.
Patients’ responses to treatment will be monitored for up to 2 years. Side effects and the safest IL-2 dose will be assessed for 1 year. Patients’ survival and survival without cancer progression will be measured for 2 years. The duration of patients’ responses to treatment will be measured for 2 years.