Non-Hodgkin's Lymphoma
Conditions
Brief summary
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.
Interventions
DRUGRiTUXimab Injection [Truxima]
375 (mg/m2) / 60 minutes
Sponsors
Laida Cuevas Palomares
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
* 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. * Ultrarapid infusion group After the administration of the 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. * Ultrarapid plus infusion group After the administration of the 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who have tolerated the maximum rate of intravenous administration of rituximab (400 mg/h) in the first or second infusion. * The last rituximab infusion must have occurred within the last 3 months. * All patients receiving rituximab can be included, regardless of whether they receive rituximab as monotherapy or in combination with chemotherapy and regardless of the line in which they are receiving it. * Patients will be included in both induction and maintenance treatment. * All patients must sign the informed consent form.
Exclusion criteria
* Patients with initial absolute lymphocyte count \>10x10\^3 cells/µL. * Patients who have presented hypersensitivity and severe adverse effects (grade II or higher) in the first or second infusion. * Severe heart failure (NYHA class III-IV) or uncontrolled severe cardiac disease. * Respiratory failure, severe uncontrolled COPD/asthma. * Patients allergic to premedication: acetaminophen or polaramine. * Severe active infection. * Pregnant patients. * Refusal to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infusional reactions | 24 hours | 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. |
Countries
Spain
Contacts
Primary ContactLaida Cuevas Palomares
Backup ContactErnesto Perez Persona
Outcome results
None listed