The efficacy of hydroxyzine pamoate or bepotastine besilate for premedication of Rituximab-induced infusion reactions: a phase II trial.

JRCT ID: jRCTs051220169

Registered date:15/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-Hodgkin lymphoma
• Date of first enrollment: 02/05/2023
• Target sample size: 40
• Study type: Interventional

Intervention(s)

The following study drugs (1) or (2) will be administered orally 30 minutes before rituximab administration in combination with acetaminophen tablets 400 mg.

(1) Hydroxyzine pamoate group
Atarax-P capsules 25 mg (enclosed in an opaque capsules)
(2) Bepotastine besilate group
Bepotastine besilate tablets 10 mg (enclosed in an opaque capsule)

Outcome(s)

• Primary Outcome: To estimate the presence of infusion reactions during the period from the start of rituximab administration to 4 hours after the start of rituximab administration.

Secondary Outcome

1. To estimate the severity of the first infusion reaction that occurred during the period up to 4 hours after the start of rituximab treatment.
2. To estimate the severity of the maximum number of infusion reactions that occurred during the period up to 4 hours after the start of rituximab treatment.
3. To estimate the time to onset of the first infusion reaction that occurred during the period up to 4 hours after initiation of rituximab.
4. To estimate the Visual Analogue Scale (VAS) value for the degree of drowsiness caused by histamine H1 receptor antagonists.
5. To estimate the incidence rate of the adverse event.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients aged 18 years or older at the time of consent acquisition.
2. Patients for whom written informed consent has been obtained regarding their voluntary participation in this clinical study.
3. Patients who are diagnosed with Non-Hodgkin lymphoma.
4. Patients who receive rituximab infusion for the first time.
5. Patients who receive rituximab alone before other anticancer agents in R-CHOP, Pola-R-CHP and BR therapy.

Exclude criteria

1. Patients who have received or will receive the following medications orally or intravenously within 48 hours of study drug administration: Antipyretic analgesics (a short half-life) and Corticosteroids.
2. Patients who received or will receive histamine H1 receptor antagonists orally or intravenously within 5 days of study drug administration.
3. Patients who have received or will receive antipyretic analgesic (a long half-life) other than 1. orally or intravenously within 10 days of study drug administration.
4. Patients who had received obinutuzumab.
drug has been administered in the past
5. Patients with renal dysfunction (Ccr< 50 mL/min).
6. Patients with liver dysfunction (Child-Pugh score C).
7. Patients with severe interstitial pneumonia.
8. Patients with porphyria.
9. Pregnant women or women who may be pregnant.
10. Patients with allergies or other drug sensitivities to the drugs used in this clinical study.
11. Patients that the investigator deems inappropriate.

Related Information

• Primary Sponsor: Minami Hironobu