Study of Skin Tests to Detect Allergies to Biotherapy Drugs for Cancer and Blood Disease Patients

What this Trial Is About

Biotherapies, which are drugs derived from living tissues or organisms, are increasingly used to treat various conditions including autoimmune diseases, cancers, and blood disorders. Many patients with cancers or hematologic diseases may receive biotherapies as part of their treatment. However, these treatments can cause side effects such as allergic reactions that are not well characterized, and there are currently no standardized guidelines for skin test concentrations to assess these hypersensitivities. This study evaluates skin tests, including prick and intradermal tests, to determine the maximum non-irritant concentration of biotherapies when investigating allergic reactions. It involves patients who have been treated with specific biotherapies like Atezolizumab, Nivolumab, Obinutuzumab, and others, having received at least two injections without suspected allergic side effects. The tests aim to establish scientific standards for skin test concentrations in line with best practice recommendations. Participants will undergo skin testing and be monitored for reactions immediately and at intervals of 48 hours and one week to identify any delayed hypersensitivity. The main outcome measured is the highest concentration of the drug that does not cause irritation, along with observing any delayed reactions. The study runs until 2028 with informed consent and appropriate medical coverage required for participation.

Evaluation of Skin Tests in Biotherapy Allergies