Pilot Study of a Microdevice Delivering 19 Drugs into Skin Lesions for Screening Treatment Effectiveness in Cutaneous and Peripheral T Cell Lymphoma

What this Trial Is About

Researchers are evaluating a microdevice designed to release up to 19 different cancer drugs directly into skin lesions of patients with cutaneous T cell lymphoma CTCL or peripheral T cell lymphoma PTCL. This pilot and feasibility study aims to assess the safety of implanting and removing this microdevice and to explore its potential as a tool to identify effective treatments for these lymphomas. The microdevice delivers very small drug doses locally to the tumor tissue, allowing analysis of tumor response without systemic exposure. Participants will have the microdevice implanted into two skin lesions, with multiple devices placed per lesion. The study includes two groups one with patients planning to start standard systemic therapy and another without immediate systemic treatment. Participants will undergo mandatory skin biopsies for additional research. The microdevice is removed after a short period to collect treated tumor tissue for analysis to evaluate local drug effects. During the study, participants will be monitored for any device-related problems or side effects, with safety assessed over two years. Researchers will analyze tumor response to the drugs using tissue samples and advanced laboratory methods including genetic and molecular testing. Standard care treatments will continue as determined by the participants doctors. Participation involves follow-up visits and laboratory testing before and after device placement, lasting up to several years for some outcome measurements.

A Pilot of a Microdevice For In Situ Candidate Drug Screening in Cutaneous Lesions of T-Cell Lymphoma