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

TerSera Therapeutics

Status and phase: Completed; Phase 2

Conditions: Oncology Patients Receiving Chemotherapy

Treatments: Drug: anti-CD20 such as Rituximab or Paclitaxel; Drug: Cetirizine HCl 10 mg/mL; Drug: Diphenhydramine 50 mg/mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT04189588

TER-QZTR-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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34 participants in 2 patient groups

Cohort A

Active Comparator group

Description:

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

Treatment:

Drug: Cetirizine HCl 10 mg/mL

Drug: anti-CD20 such as Rituximab or Paclitaxel

Cohort B

Active Comparator group

Description:

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

Treatment:

Drug: Diphenhydramine 50 mg/mL

Drug: anti-CD20 such as Rituximab or Paclitaxel