Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine

Phase 2

Completed

• Conditions: Oncology Patients Receiving Chemotherapy
• Interventions: Drug: Diphenhydramine 50 mg/mL; Drug: Cetirizine HCl 10 mg/mL; Drug: anti-CD20 such as Rituximab or Paclitaxel

• Registration Number: NCT04189588
• Lead Sponsor: TerSera Therapeutics LLC

Brief Summary

This study is designed to compare the number of infusion reactions to treatment with an anti-CD20 such as Rituxan® (rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel. Re-treatment is defined as re-treatment with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel after 6 months or in patients with persistent infusion reactions while on maintenance or retreatment.

Detailed Description

This will be a randomized, double-blind exploratory study of IV cetirizine HCl 10 mg/mL versus IV diphenhydramine 50 mg/mL in approximately 34 patients who require premedication for hypersensitivity infusion reactions associated with an anti-CD20 such as Rituxan® (rituximab) or Paclitaxel. The objectives and purpose of the study will be described to patients presenting at the participating infusion centers. The patients will be randomized to receive either IV cetirizine HCl or IV diphenhydramine.

Study Timeline

• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-04
• Study First Posted: 2019-12-06
• Study Start: 2020-03-25
• Primary Completion: 2020-11-23
• Study Completion: 2020-12-23
• Results First Submitted: 2021-11-23
• Results First Submitted QC: 2022-04-25
• Results First Posted: 2022-05-17
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Male or female patients who require treatment premedication with an antihistamine for hypersensitivity infusion reactions associated with an anti-CD20, such as Rituxan® (Rituximab) or Paclitaxel, in their first-cycle or re-treatment after 6 months or in patients with persistent infusion reactions while on maintenance or re-treatment.
• 18 years of age or older

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Exclusion Criteria

• Receipt of an investigational drug or device within the past 30 days.
• Patients with likelihood of developing or history of tumor lysis syndrome.(TLS): patients with auto-lyse, Burkitt lymphoma and diffuse large B-cell lymphoma (DLBCL) with bulky disease (single node 7 or more cm or 3 or more nodal sites with size 3 or more cm)
• Patients in whom an antihistamine may be contraindicated (e.g., narrow angle glaucoma, symptomatic prostatic hypertrophy).
• Patients who, in the opinion of the investigator, may not tolerate an IV injection of diphenhydramine 50 mg or cetirizine HCl 10 mg.
• Receipt of any antihistamine (H1 antagonist) within the past 2 hours regardless of the route of administration, e.g., diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine. chlorpheniramine, clemastine, and doxylamine
• Receipt of an H2 antagonist within the past 4 hours, e.g., ranitidine, cimetidine, famotidine, nizatidine.
• Receipt of doxepin within the past 24 hours; doxepin is an antidepressant, but it also has antihistamine properties.
• Receipt of epinephrine (EpiPen® or any other brand) within the past 30 days.
• Has known allergy to hydroxyzine, cetirizine, or levocetirizine, or diphenhydramine.
• Pregnant or breastfeeding.
• Any condition that in the view of the investigator makes the patient unsuitable for enrollment in this study.
• Major medical or psychiatric illness, other than diagnosed cancer at the time of presentation or in the past that in the investigator's judgement they should not be enrolled in this clinical trial.
• Inability to provide informed consent.
• Patients on concomitant P-glycoprotein inhibitors; including antidepressants, antipsychotics (e.g., olanzapine), and benzodiazepines (e.g., alprazolam), as they may cause an increase in sedation.
• Receipt of drugs that cause sedation within the past 24 hours prior to administration of the study drug.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort A	anti-CD20 such as Rituximab or Paclitaxel	Cetirizine HCl 10 mg/mL: a single 1 mL injection.
Cohort B	anti-CD20 such as Rituximab or Paclitaxel	Diphenhydramine 50 mg/mL: a single 1 mL injection.
Cohort B	Diphenhydramine 50 mg/mL	Diphenhydramine 50 mg/mL: a single 1 mL injection.
Cohort A	Cetirizine HCl 10 mg/mL	Cetirizine HCl 10 mg/mL: a single 1 mL injection.

Primary Outcome Measures

Name	Time	Method
Number of Hypersensitivity Reactions to Treatment With an Anti-CD20 Antibody or Paclitaxel	During and after anti-CD20 agent or paclitaxel infusion, at 1 and 2 hours after the antihistamine injection, at time of discharge, and up through 1 Month post injection of antihistamine (intervention).	Compare the number of patients experiencing any infusion reaction events, and the number and percentage of patients experiencing each symptom of infusion reactions (flushing, itching, alterations in heart rate and blood pressure, dyspnea, chest discomfort, acute back or abdominal pain, fever, shaking chills, nausea, vomiting, diarrhea, skin rashes, throat tightening, hypoxia, seizures, dizziness, or syncope) to treatment with anti-CD20 such as Rituxan® (rituximab) or Paclitaxel after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment after 6 months or in patients with persistent infusion reactions while on maintenance with anti-CD20 such as Rituxan® (rituximab) or Paclitaxel.; The infusion reactions will be evaluated following the Common Terminology Criteria for Adverse Events (CTCAE version 5.0) definitions of graded infusion reactions.

Secondary Outcome Measures

Name	Time	Method
Time From Injection to "Readiness for Discharge"	Time to discharge from infusion center	Describe the distribution of the amount of time spent in the treatment center prior to discharge (time from injection to "Readiness for Discharge").
Patient Sedation Scores at 1 Hour and 2 Hours Post-injection of Antihistamine (IV Cetirizine HCl or IV Diphenhydramine) and at Discharge.	1 hour, 2 Hours and at discharge	Patient sedation scores at 1 hour and 2 hours post-injection of antihistamine (IV cetirizine HCl or IV diphenhydramine) and at discharge. The patient sedation scores are assessed on a scale of 0-4, with 0=None and 4=Extremely Severe (Asleep, Cannot Self-Rate). The HCP sedation scores are assessed on a scale of 0-4, with 0=None and 4=Extremely severe.

Trial Locations

Locations (5)

St. Joseph Heritage Healthcare; 🇺🇸 Santa Rosa, California, United States

St.Joseph Heritage Care; 🇺🇸 Napa, California, United States

Eisenhower Medical Center; 🇺🇸 Rancho Mirage, California, United States

Baylor, Scott, & White Medical Center; 🇺🇸 Waco, Texas, United States

Oncology Consultants; 🇺🇸 Houston, Texas, United States