Prediction of Rituximab Hypersensitivity and Desensitization Treatment

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Drug Hypersensitivity Reaction

Treatments: Diagnostic Test: skin test

Study type: Interventional

Funder types: Other

Identifiers

NCT04610242

PUMCH-Allergy-01

Details and patient eligibility

About

This is a single-center prospective single arm study. The purpose of this study is to assess the usefulness of skin test as a diagnostic tool to predict the hypersensitivity to rituximab in Chinese population, evaluate the rate of hypersensitivity reactions (HSRs) after the application of active desensitization therapy in the case of a positive skin test result, and investigate the mechanism of HSRs to rituximab.

Full description

Patients with B-cell lymphomas who need the administration of rituximab are recruited. They undergo skin tests with rituximab before the first infusion of this medicine. In the case of a positive skin test result, the patient will receive the desensitization procedure; if the result of skin test is negative, the challenge test will be administered. Drug challenge test consists in administering the desired full dose of rituximab according to manufacturer instructions. Challenge is considered positive when it shows an objective HSR. The patient with a positive challenge test will receive the desensitization procedure; while the patient with a negative challenge test will be given standard rituximab infusion in the subsequent chemotherapies.

Peripheral blood will be drawn from all the subjects during their initial infusion of rituximab. If the patient shows hypersensitive symptoms, the blood will be drawn one hour after the onset of reaction; while if the patient has no HSR in the whole infusion process, the blood will be drawn at the end of infusion and used as negative control. Levels of tryptase, specific immunoglobulin E to rituximab, IL-6, IL-8, and TNF-α in the serum will be tested.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with B cell lymphoma confirmed through pathological biopsy
• Patients who need the treatment of rituximab and have not received rituximab before

Exclusion criteria

• Pregnant or lactating women
• Patients taking antihistamines in three days before the skin tests
• Long-term use of systemic corticosteroid
• Patients with skin lesions including infection, dermatitis, trauma or scar in both arms
• Patients with acute attack of asthma
• Patients with psoriasis
• Other conditions that the researchers consider inappropriate to participate in the trial

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Experimental group

Experimental group

Description:

Patients undergo diagnostic tests before the initial infusion of rituximab, including skin prick tests, intradermal tests, and challenge tests successively. If the skin test shows a positive result, the patient will receive desensitization procedure, and if the skin test is negative, the challenge test will be done, meaning normal infusion of rituximab according to manufacturer instructions. All the HSRs in the process of desensitization or normal infusion will be recorded. Peripheral blood will be drawn from all the subjects during their infusion to investigate the mechanism of HSRs to rituximab.

Treatment:

Diagnostic Test: skin test