ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
NCT ID: NCT00662948
Last Updated: 2020-04-28
Study Results
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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COMPLETED
PHASE2
149 participants
INTERVENTIONAL
2008-12-31
2017-10-30
Brief Summary
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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
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg
Ibritumomab tiuxetan
One dose of 90Y Ibritumomab tiuxetan, 0,4 mCi/Kg
B
Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months
Rituximab
375 mg/m2 every 8 weeks during 24 months
Interventions
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Rituximab
375 mg/m2 every 8 weeks during 24 months
Ibritumomab tiuxetan
One dose of 90Y Ibritumomab tiuxetan, 0,4 mCi/Kg
Eligibility Criteria
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Inclusion Criteria
* Patients no treated previously.
* Ann Arbor Stage II, III o IV.
* Symptoms or signes wich indicate necesary treatment (GELF criteria):
* Ganglionar or extraganglionar mass
* B Symptoms
* LDH or B2-microglobuline increased
* 3 ganglionar territory afected (\> 3 cm)
* Esplenomegalia
* Compresive syndrome
* Pleural/peritoneal effusion
* Secondary medular insufiency due to infiltration
* 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
* FL grade 3b.
* Skin or gastro-intestinal primary lymphoma
* History of CNS diseases ( or CNS lymphoma)
* Previous treatment
* Regulary treatment with corticosteroids (permited \< 20 mg/day prednisone or equivalent).
* Previous cancer diseases
* Major surgery in 28 days before inclusion in study.
* Creatinine \> 2,0 mg/dl (197 mmol/L)
* Bilirubin \> 2,0 mg/dl (34 mmol/L), AST (SGOT) \> 3 x upper normal limit.
* HIV infection or active infection VHB o VHC \< 4 weeks before inclusion.
* Other complicated diseases
Criteria investigador:
* Life expectancy \< 6 months.
* Hipersensibility to Ibritumomab tiuxetan, rituximab, other murines proteins or any excipients.
* Treatment in other experimental study in previous 30 days
* Any medical o psicologycal condition that can modify the capacity to give the consent
18 Years
75 Years
ALL
No
Sponsors
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GELCAB
OTHER
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
OTHER
PETHEMA Foundation
OTHER
Responsible Party
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Principal Investigators
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Canales Miguel, Dr
Role: STUDY_CHAIR
Hospital La Paz
Lopez-Guillermo Armando, Dr
Role: STUDY_CHAIR
Hospital Clinic of Barcelona
Tomas Jose Francisco, Dr
Role: STUDY_CHAIR
MD Anderson- Madrid
Locations
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Hospital Juan Canalejo
A Coruña, , Spain
Hospital de Alcorcón
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
Countries
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References
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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.
Related Links
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spanish hematology association
Other Identifiers
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ZAR2007
Identifier Type: -
Identifier Source: org_study_id
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