A Phase 2 interventional study of Cetirizine HCl 10 mg/mL and Diphenhydramine 50 mg/mL in Oncology Patients Receiving Chemotherapy, sponsored by TerSera Therapeutics LLC. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-06.
Sponsored by TerSera Therapeutics LLC · Phase 2, Interventional, and Treatment
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.
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.
TerSera Therapeutics LLC is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Cetirizine HCl 10 mg/mL: a single 1 mL injection.
Drug: Cetirizine HCl 10 mg/mL · Drug: anti-CD20 such as Rituximab or Paclitaxel
Diphenhydramine 50 mg/mL: a single 1 mL injection.
Drug: Diphenhydramine 50 mg/mL · Drug: anti-CD20 such as Rituximab or Paclitaxel
Drug page: Cetirizine
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™
Drug page: Diphenhydramine
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®
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
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.
Time frame: 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).
Patient Sedation Scores at 1 Hour and 2 Hours Post-injection of Antihistamine (IV Cetirizine HCl or IV Diphenhydramine) 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.
Time frame: 1 hour, 2 Hours and at discharge
Time From Injection to "Readiness for Discharge"
Describe the distribution of the amount of time spent in the treatment center prior to discharge (time from injection to "Readiness for Discharge").
Time frame: Time to discharge from infusion center
| Milestone | Cohort A | Cohort B |
|---|---|---|
| Started | 17 | 17 |
| Completed treatment | 17 | 17 |
| Completed | 17 | 15 |
| Not completed | 0 | 2 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
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.
| Participants | Cohort A | Cohort B |
|---|---|---|
| Number of Hypersensitivity Reactions to Treatment With an Anti-CD20 Antibody or Paclitaxel | 2 | 3 |
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.
| Units on a scale | Cohort A | Cohort B |
|---|---|---|
| 1 Hour | 0.5 ± 0.72 | 1.3 ± 1.26 |
| 2 Hour | 0.6 ± 0.61 | 0.9 ± 1.14 |
| Discharge | 0.1 ± 0.33 | 0.4 ± 0.71 |
Describe the distribution of the amount of time spent in the treatment center prior to discharge (time from injection to "Readiness for Discharge").
| Hours | Cohort A | Cohort B |
|---|---|---|
| Time From Injection to "Readiness for Discharge" | 4.3 ± 1.54 | 4.7 ± 1.26 |
Collected over 1 month. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort A | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Cohort B | 1/17 (5.9%) | 1/17 (5.9%) | 0/17 (0%) |
| Event | Cohort A | Cohort B |
|---|---|---|
| Septic ShockBlood and lymphatic system disorders | 0/17 | 1/17 |
| Age, Continuous(years) | Cohort A | Cohort B | Total |
|---|---|---|---|
| Mean | 60.4 ± 11.83 | 66.6 ± 10.16 | 63.5 ± 11.31 |
| Sex: Female, Male(Participants) | Cohort A | Cohort B | Total |
|---|---|---|---|
| Female | 6 | 6 | 12 |
| Male | 11 | 11 | 22 |
| Ethnicity (NIH/OMB)(Participants) | Cohort A | Cohort B | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 3 | 6 |
| Not Hispanic or Latino | 14 | 14 | 28 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cohort A | Cohort B | Total |
|---|---|---|---|
| United States | 17 | 17 | 34 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Cetirizine · Diphenhydramine
TerSera Therapeutics LLC