Clinical trial NCT04189588: Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine
Official title: A Phase 2 Exploratory Study of Intravenous QUZYTTIR™ (Cetirizine Hydrochloride Injection) Versus Intravenous Diphenhydramine in the Prevention of Hypersensitivity Infusion Reactions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oncology Patients Receiving Chemotherapy
Lead sponsor: TerSera Therapeutics LLC
Sponsor class: INDUSTRY
First posted: 2019-12-06
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomized Double Blind Study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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.

Primary outcomes:
measure: Number of Hypersensitivity Reactions to Treatment With an Anti-CD20 Antibody or Paclitaxel
timeFrame: 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:
measure: Patient Sedation Scores at 1 Hour and 2 Hours Post-injection of Antihistamine (IV Cetirizine HCl or IV Diphenhydramine) and at Discharge.
timeFrame: 1 hour, 2 Hours and at discharge
measure: Time From Injection to "Readiness for Discharge"
timeFrame: Time to discharge from infusion center
Other outcomes:
Locations:
city: Napa
country: United States
facility: St.Joseph Heritage Care
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: Santa Rosa
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Houston
country: United States
facility: Oncology Consultants
state: Texas
city: Round Rock
country: United States
facility: Baylor, Scott, & White Medical Center
state: Texas
city: Temple
country: United States
facility: Baylor, Scott, & White Medical Center
state: Texas
city: Waco
country: United States
facility: Baylor, Scott, & White Medical Center
state: Texas
Study officials:
affiliation: TerSera Therapeutics
name: Janine North, B.S.
role: STUDY_DIRECTOR
References:
citation: 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.