ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
Open Study in Phase II to Evaluate Efficacy of Initial R-CHOP Combination in Folicular Lymphoma no Treated Previously. Consolidation w Ith One Dose of 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
1 other identifier
interventional
149
1 country
21
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 lymphoma
Started Dec 2008
Typical duration for phase_2 lymphoma
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2008
CompletedFirst Posted
Study publicly available on registry
April 21, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2017
CompletedApril 28, 2020
April 1, 2020
5.8 years
April 8, 2008
April 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
2 years
Secondary Outcomes (5)
Saffetty of two arms
2 years
Quality of life
7 years
Global survival
7 years
Event free survival
7 years
Response rate in two arms
3 years
Study Arms (2)
A
EXPERIMENTALConsolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg
B
ACTIVE COMPARATORMaintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months
Interventions
Eligibility Criteria
You may qualify if:
- 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):
- Ganglionar or extraganglionar mass
- B Symptoms
- LDH or B2-microglobuline increased
- 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
- +2 more criteria
You may not qualify if:
- Transformation in high grade lymphoma
- 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
- Creatinine \> 2,0 mg/dl (197 mmol/L)
- Bilirubin \> 2,0 mg/dl (34 mmol/L), AST (SGOT) \> 3 x upper normal limit.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PETHEMA Foundationlead
- GELCABcollaborator
- Grupo Español de Linfomas y Transplante Autólogo de Médula Óseacollaborator
Study Sites (21)
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
Related Publications (1)
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.
PMID: 34459702DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
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 Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2008
First Posted
April 21, 2008
Study Start
December 1, 2008
Primary Completion
October 1, 2014
Study Completion
October 30, 2017
Last Updated
April 28, 2020
Record last verified: 2020-04