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| Name | Class |
|---|---|
| GELCAB | OTHER |
| Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea | OTHER |
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After conventional induction treatment with R-CHOP (Rituximab, cyclophosphamide, adriamycin, vincristine and prednisone) the patients are randomized to:
A: Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg
B: Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months
The study will evaluate the benefit of consolidation treatment with 90Y Ibritumomab tiuxetan (Zevalin®) or maintenance with rituximab (MabThera®) in terms of progression free survival, after induction with chemotherapy and rituximab in folicular lymphoma patients no treated previously.
The other aims are, evaluate the global survival, event free survival, time until next treatment, response rate after consolidation or maintenance treatment, quality of life, security of two branches and relation cost-efectivity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg |
|
| B | Active Comparator | Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | 375 mg/m2 every 8 weeks during 24 months |
| |
| Ibritumomab tiuxetan |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Saffetty of two arms | 2 years | |
| Quality of life | 7 years | |
| Global survival |
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Inclusion Criteria:
Folicular Lymphoma CD20-positive, grade 1, 2 or 3a, confirmed in previous 4 months.
Patients no treated previously.
Ann Arbor Stage II, III o IV.
Symptoms or signes wich indicate necesary treatment (GELF criteria):
Age> 18 years and <75 years.
ECOG < 2
Adecuate hematological function: Hemoglobin > 8,0 g/dl (5,0 mmol/L); RAN >1,5 x 109/L; platelets > 100 x 109/L
No pregnant women. Women and man should use an appropiate anticonceptive method during the study and one year after
Informed consent
Exclusion Criteria:
Criteria investigador:
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| Name | Affiliation | Role |
|---|---|---|
| Canales Miguel, Dr | Hospital La Paz | Study Chair |
| Lopez-Guillermo Armando, Dr | Hospital Clinic of Barcelona | Study Chair |
| Tomas Jose Francisco, Dr | MD Anderson- Madrid | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Juan Canalejo | A Coruña | Spain | ||||
| Hospital de Alcorcón |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34459702 | Derived | Lopez-Guillermo A, Canales MA, Dlouhy I, Mercadal S, Briones J, Martin Garcia-Sancho A, Sancho JM, Moraleda JM, Terol MJ, Salar A, Palomera L, Gardella S, Jarque I, Ferrer S, Bargay J, Lopez A, Panizo C, Muntanola A, Montalban C, Conde E, Hernandez MT, Soler A, Garcia Marco JA, Deben G, Marin J, Tomas JF; PETHEMA/GELTAMO/GELCAB Spanish Intergroup. A randomized phase II study comparing consolidation with a single dose of 90Y ibritumomab tiuxetan vs. maintenance with rituximab for two years in patients with newly diagnosed follicular lymphoma responding to R-CHOP. Long-term follow-up results. Leuk Lymphoma. 2022 Jan;63(1):93-100. doi: 10.1080/10428194.2021.1971216. Epub 2021 Aug 30. |
| Label | URL |
|---|---|
| spanish hematology association | View source |
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| Drug |
One dose of 90Y Ibritumomab tiuxetan, 0,4 mCi/Kg |
|
| 7 years |
| Event free survival | 7 years |
| Response rate in two arms | 3 years |
| Alcorcón |
| Spain |
| Hospital germans Trias i Pujol | Badalona | Spain |
| Hospital Clínic | Barcelona | Spain |
| Hospital de la santa Creu i Sant Pau | Barcelona | Spain |
| Hospital del Mar | Barcelona | Spain |
| Hospital Clinico San Carlos | Madrid | Spain |
| Hospital Doce de Octubre | Madrid | Spain |
| Hospital La Paz | Madrid | Spain |
| Hospital Ramón y Cajal | Madrid | Spain |
| MD Anderson | Madrid | Spain |
| Hospital Virgen de la Arrixaca | Murcia | Spain |
| Hospital son Dureta | Palma de Mallorca | Spain |
| Hospital Clínico | Salamanca | Spain |
| Hospital de Donostia | San Sebastián | Spain |
| Hoaspital Marqués de Valdecilla | Santander | Spain |
| Hospital Clínico Universitario | Santiago de Compostela | Spain |
| Hospital Clínico | Valencia | Spain |
| Hospital Dr Pesset | Valencia | Spain |
| Hospital General | Valencia | Spain |
| Hospital La Fe | Valencia | Spain |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C422802 | ibritumomab tiuxetan |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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