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

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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