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

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05191225
• Other study ID #: TxagoRapid
• Secondary ID: 2019-001750-26
• Status: Recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

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