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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001750-26 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RiTUXimab Injection [Truxima] | Drug | 375 (mg/m2) / 60 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laida Cuevas Palomares | Contact | +34945007171 | Laida.cuevaspalomares@osakidetza.eus | |
| Ernesto Perez Persona | Contact | +34945007171 | Ernesto.perezpersona@osakidetza.eus |
| Name | Affiliation | Role |
|---|---|---|
| Laida Cuevas Palomares | Bioaraba Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Araba- Sede Txagorritxu | Recruiting | Vitoria-Gasteiz | Alava | 01009 | Spain |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| RiTUXimab Injection [Truxima] |
| Drug |
375 (mg/m2) / 30 minutes |
|
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |