Status:
UNKNOWN
Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma: Txagorapid Study
Lead Sponsor:
Laida Cuevas Palomares
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05191225
Start Date
September 28 2021
End Date
December 1 2022
Last Update
March 31 2022
Active Locations (1)
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1
Hospital Universitario Araba- Sede Txagorritxu
Vitoria-Gasteiz, Alava, Spain, 01009