Prediction of Rituximab Hypersensitivity and Desensitization Treatment

NCT04610242 | Unknown

• 1 other identifier: PUMCH-Allergy-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Hypersensitivity Reaction

Keywords

Rituximab; Drug hypersensitivity reaction; Skin test; Desensitization

Outcome Measures

Primary Outcomes (1)

• Predictive value of skin test

  The sensitivity and specificity of skin test in the prediction of HSR to rituximab.

  From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks

Secondary Outcomes (6)

• Hypersensitivity reactions (HSRs)

  From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks

• Tryptase

  From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks

• Specific immunoglobulin E to rituximab

  From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks

• IL-6

  From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks

• IL-8

  From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks

Study Arms (1)

Experimental group

EXPERIMENTAL

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.

Diagnostic Test: skin test

Interventions

skin test DIAGNOSTIC_TEST

For skin prick tests (SPT), rituximab solution of 1mg/ml was applied on the volar aspect of the forearm. For intradermal tests (IDT), 0.02 mL of a 1:100 dilution (0.1mg/ml) of full-strength solution (10mg/ml) was injected first. If the result was negative, a 1:10 dilution（1mg/ml）was then used. As to the desensitization protocol, three solutions with different concentrations are delivered in 12 consecutive steps, each step increasing the rate of drug administration by 2- to 2.5-fold. Solution 1 is a 100-fold dilution (0.01mg/ml) of the final target concentration, solution 2 is a 10-fold dilution (0.1mg/ml) of the final target concentration, and the concentration of solution 3 is the target concentration (1mg/ml). Each step takes 15 minutes until the target rate of 200ml/h is reached, and the final step is prolonged to complete the target dose. The whole procedure takes about 5.5 hours.

Also known as: desensitization for patients with positive skin test results

Experimental group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Interventions

Skin Tests

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 30, 2020
• Study Start: September 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)