This study is evaluating the safety and effectiveness of a new drug called lisocabtagene maraleucel compared to standard chemotherapy for relapsed (recurrent) or refractory (does not respond to treatment) non-Hodgkin’s lymphoma (NHL). The main outcome to be measured will be time to any disease-related complication.
The details
For patients with aggressive NHL, chemoimmunotherapy remains the standard first-line treatment. While most patients respond to treatment, relapse is common. Many patients also develop tumors that no longer respond to treatment. For these patients, salvage (rescue) therapy may eliminate remaining cancer, or determine a response in refractory disease.
This study is comparing the safety and effectiveness of salvage chemotherapy versus lisocabtagene maraleucel for relapsed or refractory NHL. The main outcome will be event-free survival (time from diagnosis without a treatment-related complication) at 3 years after treatment. Side effects to the treatment will also be evaluated.
Who are they looking for?
This study is recruiting 182 participants. To participate in this study, patients must be eligible for a stem cell transplant (SCT). Patients must have developed refractory or relapsed disease within 1 year of first-line therapy and must agree to use contraception.
Patients who are planning to undergo allogeneic SCT cannot participate. Patients with a prior history of cancer cannot participate, unless they have been cancer-free for at least 2 years. Patients should not have active infections or an autoimmune disease that requires systemic therapy.
How will it work
Patients will be divided into two groups. One group will receive chemotherapy followed by lisocabtagene maraleucel. The other group (control) will receive standard salvage chemoimmunotherapy followed by high-dose chemotherapy and SCT. Event-free survival will be measured for each patient at follow-up. Patients will be followed-up for 3 years.
