Non-Hodgkin's LymphomaPhase 4NCT05191225
Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma: Txagorapid Study
A Phase 4 study testing RiTUXimab Injection [Truxima] in people with Non-Hodgkin's Lymphoma, run by Laida Cuevas Palomares at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- RiTUXimab Injection [Truxima]
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 28 Sep 2021to Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Araba- Sede Txagorritxu
Vitoria-Gasteiz, Alava, 01009
Laida Cuevas Palomares, +34945007171, Laida.cuevaspalomares@osakidetza.eus
Ernesto Perez Persona, +34945007171, Ernesto.perezpersona@osakidetza.eus
About this study
Official title: 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.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- RiTUXimab Injection [Truxima]
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiTUXimab Injection [Truxima]Drug
375 (mg/m2) / 60 minutes
RiTUXimab Injection [Truxima]Drug
375 (mg/m2) / 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: RiTUXimab Injection [Truxima] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start28 Sep 2021
- Primary completionMar 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laida Cuevas Palomares
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Laida Cuevas Palomares, Bioaraba Health Research Institute
- Investigators
- Laida Cuevas Palomares, Principal investigator, Bioaraba Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191225
- Sponsor's protocol ID
- TxagoRapid
- Other IDs
- 2019-001750-26, 2019
- Status last verified
- Mar 2022
- First submitted
- 29 Dec 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma: Txagorapid Study - Intervention Pilot Study
- ClinicalTrials.gov ID
- NCT05191225
- Acronym / sponsor ID
- TxagoRapid
- Conditions
- Non-Hodgkin's Lymphoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Laida Cuevas PalomaresResearch network
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Rapid infusion group | Experimental | Drug: RiTUXimab Injection [Truxima]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 | Experimental | Drug: RiTUXimab Injection [Truxima]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. |
| Ultrarapid plus infusion group | Experimental | Drug: RiTUXimab Injection [Truxima]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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RiTUXimab Injection [Truxima]375 (mg/m2) / 60 minutes | Drug | Rapid infusion group |
| RiTUXimab Injection [Truxima]375 (mg/m2) / 30 minutes | Drug | Ultrarapid infusion group, Ultrarapid plus infusion group |
Primary outcome
Infusional reactions
Time frame: 24 hours
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laida Cuevas Palomares principal investigator
Bioaraba Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RiTUXimab Injection [Truxima] in people with Non-Hodgkin's Lymphoma, run by Laida Cuevas Palomares at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laida Cuevas Palomares (+34945007171, Laida.cuevaspalomares@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infusional reactions (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.