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

INTERVENTION: 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) CONDITION: Non‐Hodgkin lymphoma 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. INCLUSION 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.