This study is investigating how well nivolumab (Opdivo) works with DA-REPOCHchemotherapy for treating aggressive B-cell non-Hodgkin's lymphoma (NHL). The primary outcome to be measured is 2-year survival without disease progression after treatment. This study is being conducted in Columbus, OH, in the United States.
The details
Chemoimmunotherapy is the typical first-line treatment for aggressive NHL. This treatment combines chemotherapy with immunotherapy. Nivolumab is a monoclonal antibody. This type of immunotherapy may help the body's immune system attack cancer cells. Chemotherapy regimens such as DA-REPOCH kill cancer cells by stopping their growth or spread.
This study is investigating how well nivolumab plus DA-REPOCHchemotherapy can treat aggressive B-cell NHL. The primary outcome to be measured is 2-year survival without disease progression after treatment.
Who are they looking for?
This study is looking for 30 patients with B-cell NHL. Female patients must have a negative pregnancy test before study entry. All patients must agree to use contraception. Female patients who are pregnant or breastfeeding cannot participate.
Patients who had prior chemotherapy for lymphoma cannot participate. Patients who are sensitive or allergic to any of the study drugs cannot participate. Patients with HIV, tuberculosis, hepatitis B, or hepatitis C cannot participate. Patients with active infections, heart problems, or an autoimmune disease cannot participate. Patients who are planning to have major surgery within 3 weeks of study entry cannot participate.
How will it work
All patients will receive nivolumab plus DA-REPOCH chemotherapy for six courses of treatment. Then, patients will be given up to six additional courses of nivolumab only.
Patients will be followed up at 30 days, every three months for three years. Then, follow-up will repeat every six months for five years. The primary outcome to be measured is survival without disease progression at two years after treatment. The number of patients who respond to treatment will also be measured for up to 8 years.
