A Study in Adults With Cutaneous T-Cell Lymphoma (CTCL) Who Underwent Retreatment With Brentuximab Vedotin

Cutaneous T-cell lymphoma (CTCL) is a type of non-Hodgkin lymphoma that affects T-lymphocytes, a subtype of white blood cells that are part of the body’s immune system. These lymphocytes undergo uncontrolled growth and primarily affect the skin of those affected. There are numerous subtypes of CTCL; the most common form is mycosis fungoides. The most common symptoms include swollen lymph nodes, an enlarged liver or spleen, and nonspecific inflammation of the skin. Treatment options include radiation therapy, light therapy, topical corticosteroid application, and chemotherapy (applied topically to the skin and systemically). Systemic therapy is recommended if the disease is uncontrollable (refractory) or if there is a recurrence of the disease.

The aim of this observational study is to further investigate the efficacy of the recently approved drug brentuximab vedotin, particularly in situations where brentuximab has already been administered and is now to be administered again. Brentuximab vedotin is an antibody-drug conjugate that specifically binds to a surface receptor on cancer cells, penetrates the cancer cell, and releases a toxic agent inside the cell. The drug is already approved for the treatment of CTCL. No specific therapy will be administered as part of the study; the study will solely observe the effect of taking brentuximab. After the last dose is administered, patients will be monitored for 4 months, and follow-up visits are planned for at least 12 months. The primary endpoints of the study include the response rate, the response to treatment at 12 months, and progression-free survival at 24 months.

Patients aged 18 and older with CTCL are eligible to participate in this study. Participants must have been pretreated with at least two cycles of brentuximab vedotin.