Brentuximab + Lenalidomide for T-Cell Lymphoma

This trial tests a combination of two treatments: brentuximab vedotin (an antibody-drug conjugate) and lenalidomide (an immunomodulatory drug), to evaluate their effectiveness against T-cell lymphoma, a cancer affecting the immune system. The researchers aim to determine if these drugs can effectively treat the cancer, particularly in patients whose cancer has returned or didn’t respond to previous treatments. Individuals who have tried at least two skin treatments or one systemic (whole-body) treatment for their T-cell lymphoma and have measurable disease might be suitable candidates for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

The trial requires that all cancer therapies, including radiation, topical steroids, and chemotherapy, be stopped at least one week or three half-lives before starting the study treatment. However, if you have been on corticosteroids for more than 60 days without changes, you may continue them. You can also continue medications for other conditions if there is evidence of T-cell lymphoma progression while on those medications.

Research has shown that the combination of brentuximab vedotin and lenalidomide has been tested in patients with certain types of lymphoma. Studies have found that this combination has a manageable safety profile, meaning that while side effects exist, most patients can tolerate them.

The FDA has already approved brentuximab vedotin for some types of lymphoma, indicating that its safety is well understood. Lenalidomide, a chemotherapy drug, stops cancer cells from growing and dividing. Previous studies have used this combination in patients who have undergone several treatments, and the safety results were acceptable.

Researchers are excited about the combination of brentuximab vedotin and lenalidomide for T-cell lymphoma because it brings a fresh approach compared to standard treatments like chemotherapy and radiation. Brentuximab vedotin is an antibody-drug conjugate that specifically targets CD30-positive cancer cells, delivering a potent drug directly to the tumor while minimizing damage to healthy cells. Lenalidomide, on the other hand, enhances the immune system's ability to fight cancer. This combination not only targets the cancer cells directly but also boosts the body's natural defenses, offering a two-pronged attack that could improve outcomes for patients with this challenging type of lymphoma.

Research has shown that the drugs brentuximab vedotin and lenalidomide can each help treat certain types of T-cell lymphoma. Studies found that 57% of patients experienced a positive response, meaning their cancer improved with the treatment. On average, patients lived just over 10 months without their cancer worsening. This trial will administer a combination of brentuximab vedotin and lenalidomide, as strong evidence suggests that using these two drugs together could effectively treat T-cell lymphoma that has returned or is hard to treat.¹²⁶⁷⁸