AL Amyloidosis, Bronchial Carcinoma, Cholangiocarcinoma, Chronic Lymphocytic Leukemia, Colorectal Adenocarcinoma, Colorectal Cancer, Esophageal Squamous Cell Carcinoma, Follicular Lymphoma, Heart Cancer, Hepatocarcinoma, Hodgkin's Lymphoma, Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck, Melanoma Neoplasms, Myeloma, Pleural Mesothelioma, Small Cell Bronchial Carcinomas
Conditions
Brief summary
Biotherapies are biological (extracted from an organism or living tissue) or biotechnological drugs used in the treatment of multiple conditions, such as autoimmune inflammatory diseases, cancers, and hematologic diseases. In recent years, these biotherapies have notably emerged in the treatment of cancers and hematologic disorders. As such, most patients with cancers or hematologic diseases will likely receive a biotherapy as part of their care pathway. These biotherapies are associated with various side effects, including hypersensitivity or allergic reactions, which are often poorly characterized in clinical trials. These reactions manifest as symptoms without specific dermatologic or allergologic semiology (such as itching, erythema, shortness of breath, sometimes digestive issues, or discomfort, and in some cases, an anaphylactic reaction). Unlike other treatments, such as antibiotics and neuromuscular blockers, there are currently no guidelines on the concentrations to use in skin tests for biotherapies. We propose conducting prospective clinical research to scientifically establish the concentrations to be used when investigating hypersensitivity to a biotherapy, in line with best practice recommendations for drug skin testing.
Interventions
OTHERDrug skin tests (investigating hypersensitivity to a biotherapy)
allergologic skin tests (prick tests and intradermal tests)
Sponsors
University Hospital, Angers
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
: * Patient treated with one of the biotherapies under study (Atezolizumab 1200 mg, Nivolumab 480 mg, Obinutuzumab 100 mg, Durvalumab 1500 mg, Pembrolizumab 200 mg, Daratumumab 1800 mg, Cemiplimab 3500 mg) and who has received at least two injections of the biotherapy without suspected allergic side effects. * Subjects covered by or having the rights to medical care assurance * Written informed consent obtained from subject * If applicable, treatment with corticosteroids and H1 antihistamines by systemic route (IV or oral) which may be discontinued at least one week before performing the tests (Inhaled corticosteroids are allowed).
Exclusion criteria
* Presence of local or diffuse dermatological lesions (e.g., psoriasis, eczema, ...) that could interfere with the interpretation of skin tests. * Poor understanding of the French language * Pregnancy, breastfeeding * Persons in detention by judicial or administrative decision * Person admitted to a health or social establishment for purposes other than research * Person subject to a legal protection measure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maximum usable concentration considered non-irritant | Day 1 | For each biotherapy studied, the maximum usable concentration considered non-irritant is defined as the maximum concentration that does not produce a skin reaction in at least 9 out of 10 patients (90% specificity) during skin testing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| possible occurrence of a delayed reaction at 48 hours post-testing | Day 2 | delayed reaction is considered if, at the intradermal injection sites, a skin reaction occurs 48 hours after injection, or if a systemic reaction occurs following biotherapy administration. |
| possible occurrence of a delayed reaction at one week post-testing | Day 7 | delayed reaction is considered if, at the intradermal injection sites, a skin reaction occurs 1 week after injection |
Countries
France
Contacts
CONTACTMartine MORISSET
CONTACTAnthéa LOIEZ
PRINCIPAL_INVESTIGATORMartine MORISSET
University Hospital, Angers
Outcome results
None listed