Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma: Txagorapid Study

Sponsor
Laida Cuevas Palomares
Study ID
NCT05191225
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Jan 13, 2022
Start date
Sep 28, 2021
Status verified
Mar 2022
Primary completion
Mar 31, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Rapid infusion group
    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.
  • Experimental: Ultrarapid infusion group
    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.
  • Experimental: Ultrarapid plus infusion group
    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.

Primary Outcome Measure

Infusional reactions [ Time Frame: 24 hours ]

Central Contacts

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