Phase 12 Study of Durvalumab Alone or With Lenalidomide to Treat Relapsed or Resistant Cutaneous and Peripheral T-Cell Lymphoma

What this Trial Is About

Researchers are studying the best dose and side effects of durvalumab, a monoclonal antibody, with or without lenalidomide, a chemotherapy drug, in treating patients whose cutaneous or peripheral T cell lymphoma has returned or does not respond to treatment. This phase III randomized trial aims to find the optimal dose of lenalidomide combined with durvalumab and to evaluate the safety, tolerability, and anti-tumor activity of these treatments. The study also explores biological markers that may predict response or toxicity. Participants are randomly assigned to one of two groups. In one group, patients receive durvalumab intravenously once every 28 days for up to 13 cycles, unless the disease progresses or unacceptable side effects occur. In the other group, patients receive the same durvalumab treatment combined with oral lenalidomide daily for 21 days of each 28-day cycle, also up to 13 cycles under similar conditions. After completing the treatment phase, patients are followed for up to 12 months to monitor their health and response. During the study, participants undergo various tests and evaluations including response assessments by standard lymphoma criteria, toxicity monitoring, and quality-of-life measurements such as reduction in itching for cutaneous T-cell lymphoma. Researchers collect laboratory samples and monitor immune cells to understand treatment effects. Safety is closely tracked for up to 90 days after treatment ends. Overall survival and event-free survival are also measured, with total participation lasting over a year from treatment start through follow-up.

Durvalumab With or Without Lenalidomide in Treating Patients With Relapsed or Refractory Cutaneous or Peripheral T Cell Lymphoma