Clinical trial · Interventional
Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma: Txagorapid Study
Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma: Txagorapid Study - Intervention Pilot Study
NCT05191225CI-TRIAL-00057441unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RiTUXimab Injection [Truxima] | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Rapid infusion group
- description
- 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.
- interventionNames
- Drug: RiTUXimab Injection [Truxima]
- type
- EXPERIMENTAL
- label
- Ultrarapid infusion group
- description
- 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.
- interventionNames
- Drug: RiTUXimab Injection [Truxima]
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.