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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-28

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

* 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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

RiTUXimab Injection [Truxima]

Intervention Type DRUG

375 (mg/m2) / 60 minutes

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.

Group Type EXPERIMENTAL

RiTUXimab Injection [Truxima]

Intervention Type DRUG

375 (mg/m2) / 30 minutes

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.

Group Type EXPERIMENTAL

RiTUXimab Injection [Truxima]

Intervention Type DRUG

375 (mg/m2) / 30 minutes

Interventions

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RiTUXimab Injection [Truxima]

375 (mg/m2) / 60 minutes

Intervention Type DRUG

RiTUXimab Injection [Truxima]

375 (mg/m2) / 30 minutes

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No