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

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
RiTUXimab Injection [Truxima]
RiTUXimab Injection [Truxima]
Sponsored by
Laida Cuevas Palomares
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario Araba- Sede TxagorritxuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Rapid infusion group

Ultrarapid infusion group

Ultrarapid plus infusion group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 29, 2021
Last Updated
March 30, 2022
Sponsor
Laida Cuevas Palomares
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1. Study Identification

Unique Protocol Identification Number
NCT05191225
Brief Title
Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma: Txagorapid Study
Official Title
Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma: Txagorapid Study - Intervention Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Laida Cuevas Palomares

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rapid infusion group
Arm Type
Experimental
Arm Description
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.
Arm Title
Ultrarapid infusion group
Arm Type
Experimental
Arm Description
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.
Arm Title
Ultrarapid plus infusion group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
RiTUXimab Injection [Truxima]
Intervention Description
375 (mg/m2) / 60 minutes
Intervention Type
Drug
Intervention Name(s)
RiTUXimab Injection [Truxima]
Intervention Description
375 (mg/m2) / 30 minutes
Primary Outcome Measure Information:
Title
Infusional reactions
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laida Cuevas Palomares
Phone
+34945007171
Email
Laida.cuevaspalomares@osakidetza.eus
First Name & Middle Initial & Last Name or Official Title & Degree
Ernesto Perez Persona
Phone
+34945007171
Email
Ernesto.perezpersona@osakidetza.eus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laida Cuevas Palomares
Organizational Affiliation
Bioaraba Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Araba- Sede Txagorritxu
City
Vitoria-Gasteiz
State/Province
Alava
ZIP/Postal Code
01009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laida Cuevas Palomares
Phone
+34945007171
Email
Laida.cuevaspalomares@osakidetza.eus
First Name & Middle Initial & Last Name & Degree
Ernesto Perez Persona
Phone
+34945007171
Email
Ernesto.perezpersona@osakidetza.eus

12. IPD Sharing Statement

Learn more about this trial

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

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