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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Hodgkin's Lymphoma
• Intervention / Treatment: Drug: RiTUXimab Injection [Truxima]; Drug: RiTUXimab Injection [Truxima]

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Laida Cuevas Palomares; Phone Number: +34945007171; Email: Laida.cuevaspalomares@osakidetza.eus
• Study Contact Backup: Name: Ernesto Perez Persona; Phone Number: +34945007171; Email: Ernesto.perezpersona@osakidetza.eus

Study Locations

• Spain
  • Alava
    • Vitoria-Gasteiz, Alava, Spain, 01009
      • Recruiting
      • Hospital Universitario Araba- Sede Txagorritxu
      • Contact: Laida Cuevas Palomares; Phone Number: +34945007171; Email: Laida.cuevaspalomares@osakidetza.eus
      • Contact: Ernesto Perez Persona; Phone Number: +34945007171; Email: Ernesto.perezpersona@osakidetza.eus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: RiTUXimab Injection [Truxima]; 375 (mg/m2) / 60 minutes; Drug: RiTUXimab Injection [Truxima]; 375 (mg/m2) / 30 minutes
EXPERIMENTAL: Ultrarapid infusion group; 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]; 375 (mg/m2) / 60 minutes; Drug: RiTUXimab Injection [Truxima]; 375 (mg/m2) / 30 minutes
EXPERIMENTAL: Ultrarapid plus infusion group; 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]; 375 (mg/m2) / 60 minutes; Drug: RiTUXimab Injection [Truxima]; 375 (mg/m2) / 30 minutes

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laida Cuevas Palomares
• Investigators: Principal Investigator: Laida Cuevas Palomares, Bioaraba Health Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 28, 2021
• Primary Completion (ANTICIPATED): March 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: December 29, 2021
• First Posted (ACTUAL): January 13, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab
• Other Study ID Numbers: TxagoRapid; 2019-001750-26 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No