Non-Hodgkin lymphoma
Conditions
Interventions
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 ca
Sponsors
Minami Hironobu
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactYumi Kitahiro
Kobe University Hospital
Outcome results
None listed