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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05191225
Other study ID # TxagoRapid
Secondary ID 2019-001750-26
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 28, 2021
Est. completion date December 2022

Study information

Verified date March 2022
Source Bioaraba Health Research Institute
Contact Laida Cuevas Palomares
Phone +34945007171
Email Laida.cuevaspalomares@osakidetza.eus
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date December 2022
Est. primary completion date March 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
RiTUXimab Injection [Truxima]
375 (mg/m2) / 60 minutes
RiTUXimab Injection [Truxima]
375 (mg/m2) / 30 minutes

Locations

Country Name City State
Spain Hospital Universitario Araba- Sede Txagorritxu Vitoria-Gasteiz Alava

Sponsors (1)

Lead Sponsor Collaborator
Laida Cuevas Palomares

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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