Prediction of Rituximab Hypersensitivity and Desensitization Treatment

Not Applicable

• Conditions: Drug Hypersensitivity Reaction

• Registration Number: NCT04610242
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09-01
• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-10-26
• Last Update Submitted: 2020-10-26
• Study First Posted: 2020-10-30
• Last Update Posted: 2020-10-30
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Predictive value of skin test	From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks	The sensitivity and specificity of skin test in the prediction of HSR to rituximab.

Secondary Outcome Measures

Name	Time	Method
Specific immunoglobulin E to rituximab	From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks	Level of serum specific immunoglobulin E to rituximab
IL-6	From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks	Level of serum IL-6
IL-8	From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks	Level of serum IL-8
Hypersensitivity reactions (HSRs)	From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks	The rate of HSRs in all the enrolled subjects with the application of active desensitization therapy in the case of a positive skin test result.
Tryptase	From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks	Level of serum tryptase
TNF-α	From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks	Level of serum TNF-α

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China