Phase 2 Study IV QUZYTTIR™ (Cetirizine Hydrochloride Injection) vs V Diphenhydramine
Condition: Oncology Patients Receiving Chemotherapy
MeSH terms: Neoplasms
Intervention: Cetirizine HCl 10 mg/mL; Diphenhydramine 50 mg/mL; anti-CD20 such as Rituximab or Paclitaxel
Intervention description: 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; 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; 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.
Intervention MeSH terms: Diphenhydramine; Promethazine; Cetirizine; Paclitaxel; Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Randomized Double Blind Study
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double Blind
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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.