Clinical trial NCT00662948: ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
Official title: 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®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: Folicular Lymphoma
Consolidation
Maintenance
Lead sponsor: PETHEMA Foundation
Sponsor class: OTHER
Collaborators: name: GELCAB
name: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
First posted: 2008-04-21
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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

Eligibility criteria: 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):

  * 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:

* 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
* 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

Primary outcomes:
measure: Progression free survival
timeFrame: 2 years
Secondary outcomes:
measure: Saffetty of two arms
timeFrame: 2 years
measure: Quality of life
timeFrame: 7 years
measure: Global survival
timeFrame: 7 years
measure: Event free survival
timeFrame: 7 years
measure: Response rate in two arms
timeFrame: 3 years
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Hospital de Alcorcón
city: Badalona
country: Spain
facility: Hospital germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Clínic
city: Barcelona
country: Spain
facility: Hospital de la santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
city: La Coruña
country: Spain
facility: Hospital Juan Canalejo
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: MD Anderson
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Palma de Mallorca
country: Spain
facility: Hospital son Dureta
city: Salamanca
country: Spain
facility: Hospital Clínico
city: San Sebastián
country: Spain
facility: Hospital de Donostia
city: Santander
country: Spain
facility: Hoaspital Marqués de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario
city: V Alencia
country: Spain
facility: Hospital General
city: Valencia
country: Spain
facility: Hospital Clínico
city: Valencia
country: Spain
facility: Hospital Dr Pesset
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
affiliation: Hospital La Paz
name: Canales Miguel, Dr
role: STUDY_CHAIR
affiliation: Hospital Clinic of Barcelona
name: Lopez-Guillermo Armando, Dr
role: STUDY_CHAIR
affiliation: MD Anderson- Madrid
name: Tomas Jose Francisco, Dr
role: STUDY_CHAIR
References:
citation: 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.