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Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma
NCT05191225Phase 4
Key facts
- Status
- Unknown
- Start
- Sep 2021
- Primary completion
- Mar 2022
- Countries
- 1
- Modality
- Monoclonal Antibodies
- Drugs
- rituximab
- Conditions
- non-Hodgkin lymphoma (NHL)
01
Overview
Phase 4, open-label trial of rituximab in non-Hodgkin lymphoma (NHL) (3 arms). Primary endpoint: Infusional reactions at 24 hours. Status: unknown.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
Rapid infusion group
Standard dose in 1 hour
Ultrarapid infusion group
Standard dose in 30 minutes
Ultrarapid plus infusion group
Standard dose in 30 minutes with oral premedication
03
Who it enrols
Patients with Non-Hodgkin's Lymphoma who have tolerated previous rituximab infusions at the maximum rate (400 mg/h). Excludes patients with high lymphocyte counts, severe heart failure, or respiratory failure.
04
Endpoints
Primary
Infusional reactions
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