A Phase 4 interventional study of RiTUXimab Injection [Truxima] and RiTUXimab Injection [Truxima] in Non-Hodgkin's Lymphoma, sponsored by Laida Cuevas Palomares. Status unknown at 1 site in Spain. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Laida Cuevas Palomares · Phase 4, Interventional, and Treatment
The objective of this pilot study is therefore to assess the safety of Truxima ultrafast infusion within 30 minutes in patients with non-Hodgkin's lymphoma.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 48 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →This is the only study on the registry with Laida Cuevas Palomares as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
After the administration of intravenous premedication (usually dexchlorpheniramine 5 mg IV and paracetamol 1 g IV), rituximab will be administered at standard dose (375 mg/m2 diluted in 250 ml of saline) administered in one hour, divided into: 10 first minutes at 450 mg/hour, and 50 minutes later at 720 mg/hour.
Drug: RiTUXimab Injection [Truxima]
After the administration of intravenous premedication, the dose of rituximab will be administered at standard dose administered in half an hour, divided into: 10 first minutes at 450 mg/hour, and 20 minutes later at 1800mg/hour.
Drug: RiTUXimab Injection [Truxima]
After the administration of oral premedication, the dose of rituximab will be administered at the standard dose administered in half an hour, divided into: 10 first minutes at 450 mg/hour, and 20 minutes later at 1800mg/hour.
Drug: RiTUXimab Injection [Truxima]
375 (mg/m2) / 60 minutes
375 (mg/m2) / 30 minutes
Infusional reactions
Percentage of grade 2/3 or higher infusion reactions in rapid, ultrafast and ultrafast plus infusion compared to rituximab administration following standard clinical practice at standard rate of 400 mg/h.
Time frame: 24 hours
This study is status unknown, as verified in Mar 2022. 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.