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

NCT04189588 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TER-QZTR-001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 7

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.

Conditions

Oncology Patients Receiving Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Number of Hypersensitivity Reactions to Treatment With an Anti-CD20 Antibody or Paclitaxel

  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.

  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).

Secondary Outcomes (2)

• 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

• Time From Injection to "Readiness for Discharge"

  Time to discharge from infusion center

Study Arms (2)

Cohort A

ACTIVE COMPARATOR

Cetirizine HCl 10 mg/mL: a single 1 mL injection.

Drug: Cetirizine HCl 10 mg/mL; Drug: anti-CD20 such as Rituximab or Paclitaxel

Cohort B

ACTIVE COMPARATOR

Diphenhydramine 50 mg/mL: a single 1 mL injection.

Drug: Diphenhydramine 50 mg/mL; Drug: anti-CD20 such as Rituximab or Paclitaxel

Interventions

Cetirizine HCl 10 mg/mL DRUG

Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe

Also known as: Quzyttir™

Cohort A

Diphenhydramine 50 mg/mL DRUG

Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe

Also known as: Benadryl injection®

Cohort B

anti-CD20 such as Rituximab or Paclitaxel DRUG

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. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment.

Also known as: Rituxan®, Taxol, Arzerra, Ocrevus, Gazyva, Ruxience, Truxima, Zevalin

Cohort A; Cohort B

Eligibility Criteria

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

You may qualify if:

• 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.
• years of age or older

You may not qualify if:

• 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.

Sponsors & Collaborators

• TerSera Therapeutics LLC: lead

Study Sites (7)

St.Joseph Heritage Care

Napa, California, 94558, United States

Location

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

Location

St. Joseph Heritage Healthcare

Santa Rosa, California, 95403, United States

Location

Oncology Consultants

Houston, Texas, 77030, United States

Location

Baylor, Scott, & White Medical Center

Round Rock, Texas, 78665, United States

Location

Baylor, Scott, & White Medical Center

Temple, Texas, 76508, United States

Location

Baylor, Scott, & White Medical Center

Waco, Texas, 76712, United States

Location

Related Publications (1)

• Holmes JP, Peguero JA, Garland RC, North J, Young S, Brent LD, Joseph-Ridge N. Intravenous Cetirizine vs Intravenous Diphenhydramine for the Prevention of Hypersensitivity Infusion Reactions: Results of an Exploratory Phase 2 Study. J Infus Nurs. 2021 Nov-Dec 01;44(6):315-322. doi: 10.1097/NAN.0000000000000444.

  PMID: 34555839 DERIVED

Related Links

• Results Publication in Journal of Infusion Nursing: Intravenous Cetirizine vs Intravenous Diphenhydramine for the Prevention of Hypersensitivity Infusion Reactions: Results of an Exploratory Phase 2 Study

MeSH Terms

Interventions

Cetirizine; Diphenhydramine; Rituximab; Paclitaxel; ofatumumab; ocrelizumab; obinutuzumab; ibritumomab tiuxetan

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Results Point of Contact

• Title: Executive Director Clinical Development
• Organization: TerSera Therapeutics Inc.

jnorth@tersera.com

888 600 8116

Study Officials

• Janine North, B.S.

  TerSera Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized Double Blind Study

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 6, 2019
• Study Start: March 25, 2020
• Primary Completion: November 23, 2020
• Study Completion: December 23, 2020
• Last Updated: October 6, 2023
• Results First Posted: May 17, 2022

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)