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

Phase 2

Recruiting

• Conditions: on-Hodgkin lymphoma

• Registration Number: JPRN-jRCTs051220169
• Lead Sponsor: Minami Hironobu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-15
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified