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

Study Overview
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Brief Summary
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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.

Official Title
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Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma: Txagorapid Study - Intervention Pilot Study

Conditions
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Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: RiTUXimab Injection [Truxima]
* Drug: RiTUXimab Injection [Truxima]


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapid infusion group<br>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]<br>* 375 (mg/m2) / 60 minutes<br>|
| Experimental: Ultrarapid infusion group<br>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]<br>* 375 (mg/m2) / 30 minutes<br>|
| Experimental: Ultrarapid plus infusion group<br>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]<br>* 375 (mg/m2) / 30 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 hours |