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

Laida Cuevas Palomares

Status and phase: Unknown; Phase 4

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: RiTUXimab Injection [Truxima]

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05191225

2019-001750-26 (EudraCT Number)

TxagoRapid

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

Rapid infusion group

Experimental group

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.

Treatment:

Drug: RiTUXimab Injection [Truxima]

Drug: RiTUXimab Injection [Truxima]

Ultrarapid infusion group

Experimental group

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.

Treatment:

Drug: RiTUXimab Injection [Truxima]

Drug: RiTUXimab Injection [Truxima]

Ultrarapid plus infusion group

Experimental group

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.

Treatment:

Drug: RiTUXimab Injection [Truxima]

Drug: RiTUXimab Injection [Truxima]