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

NCT05191225 | Unknown Phase 4

• 2 other identifiers: TxagoRapid2019-001750-26
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Rapid infusion group

EXPERIMENTAL

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]

Ultrarapid infusion group

EXPERIMENTAL

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]

Ultrarapid plus infusion group

EXPERIMENTAL

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]

Interventions

RiTUXimab Injection [Truxima] DRUG

375 (mg/m2) / 60 minutes

Rapid infusion group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laida Cuevas Palomares: lead

Study Sites (1)

Hospital Universitario Araba- Sede Txagorritxu

Vitoria-Gasteiz, Alava, 01009, Spain

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Laida Cuevas Palomares

  Bioaraba Health Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laida Cuevas Palomares

CONTACT

+34945007171; Laida.cuevaspalomares@osakidetza.eus

Ernesto Perez Persona

CONTACT

+34945007171; Ernesto.perezpersona@osakidetza.eus

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. specialist in hematology and hemotherapy

Model Details: * 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. * Ultrarapid infusion group After the administration of the 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. * Ultrarapid plus infusion group After the administration of the 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.

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 13, 2022
• Study Start: September 28, 2021
• Primary Completion: March 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

ES (1)