Clinical trial NCT04610242: Prediction of Rituximab Hypersensitivity and Desensitization Treatment
Official title: Prediction of Rituximab Hypersensitivity and Desensitization Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drug Hypersensitivity Reaction
Keywords: Rituximab
Drug hypersensitivity reaction
Skin test
Desensitization
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Predictive value of skin test
timeFrame: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
Secondary outcomes:
measure: Hypersensitivity reactions (HSRs)
timeFrame: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
measure: Tryptase
timeFrame: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
measure: Specific immunoglobulin E to rituximab
timeFrame: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
measure: IL-6
timeFrame: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
measure: IL-8
timeFrame: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
measure: TNF-α
timeFrame: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: