Drug Hypersensitivity ReactionNCT04610242
Prediction of Rituximab Hypersensitivity and Desensitization Treatment
A study testing skin test in people with Drug Hypersensitivity Reaction, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug Hypersensitivity Reaction
- What is being tested?
- skin test
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with B cell lymphoma confirmed through pathological biopsy
- Patients who need the treatment of rituximab and have not received rituximab before
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Lisha Li, 8613661359318, doctorlilisha@163.com
Yan Zhang, 8613810000485, zhangyan10659@pumch.cn
About this study
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.
Read the 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.
- Conditions
- Drug Hypersensitivity Reaction
- Being tested
- skin test
- Keywords
- Rituximab, Drug hypersensitivity reaction, Skin test, Desensitization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin testDiagnostic test
Also called desensitization for patients with positive skin test results
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: skin test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of skin test
The sensitivity and specificity of skin test in the prediction of HSR to rituximab.
Measured: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
Secondary outcomes (6)
Hypersensitivity reactions (HSRs)
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.
Measured: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
Tryptase
Level of serum tryptase
Measured: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
Specific immunoglobulin E to rituximab
Level of serum specific immunoglobulin E to rituximab
Measured: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
IL-6
Level of serum IL-6
Measured: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
IL-8
Level of serum IL-8
Measured: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
TNF-α
Level of serum TNF-α
Measured: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start1 Sep 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Hypersensitivity ReactionStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610242
- Sponsor's protocol ID
- PUMCH-Allergy-01
- Status last verified
- Sep 2020
- First submitted
- 25 Sep 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Rituximab Hypersensitivity and Desensitization Treatment
- ClinicalTrials.gov ID
- NCT04610242
- Acronym / sponsor ID
- PUMCH-Allergy-01
- Conditions
- Drug Hypersensitivity Reaction
- Keywords
- Rituximab, Drug hypersensitivity reaction, Skin test, Desensitization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Diagnostic Test: skin testPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with B cell lymphoma confirmed through pathological biopsy
- Patients who need the treatment of rituximab and have not received rituximab before
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin testAlso: desensitization for patients with positive skin test resultsFor 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. | Diagnostic test | Experimental group |
Primary outcome
Predictive value of skin test
Time frame: 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.
6 secondary outcomes
Hypersensitivity reactions (HSRs)
Time frame: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
Tryptase
Time frame: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
Specific immunoglobulin E to rituximab
Time frame: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
IL-6
Time frame: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
IL-8
Time frame: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
TNF-α
Time frame: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin test in people with Drug Hypersensitivity Reaction, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of skin test (time frame: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2020.