CompletedNCT00662948Updated Apr 28, 2020

ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)

A Phase 2 interventional study of Rituximab and Ibritumomab tiuxetan in Lymphoma, sponsored by PETHEMA Foundation. Completed at 21 sites in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-04-28.

Sponsored by PETHEMA Foundation · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 149
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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

Read the 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

Conditions studied

Lymphoma

Browse trials for

Lymphoma 5,578

Keywords

Folicular Lymphoma
Consolidation
Maintenance

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 149 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

PETHEMA Foundation is the lead sponsor of 104 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 149 participants (actual)

Study arms

Experimental
A
Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg
Drug: Ibritumomab tiuxetan
Active comparator
B
Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months
Drug: Rituximab

Interventions

DrugRituximab
375 mg/m2 every 8 weeks during 24 months
DrugIbritumomab tiuxetan
One dose of 90Y Ibritumomab tiuxetan, 0,4 mCi/Kg

What researchers measure

Primary outcomes

Progression free survival
Time frame: 2 years

Secondary outcomes

Saffetty of two arms
Time frame: 2 years
Quality of life
Time frame: 7 years
Global survival
Time frame: 7 years
Event free survival
Time frame: 7 years
Response rate in two arms
Time frame: 3 years

Study locations

21 sites

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 Juan Canalejo
La Coruña, 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 General
V Alencia, Spain
Hospital Clínico
Valencia, Spain
Hospital Dr Pesset
Valencia, Spain
Hospital La Fe
Valencia, Spain

References and documents

Publications

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. PubMed 34459702 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00662948
Lead sponsor: PETHEMA Foundation
Collaborators: GELCAB, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Responsible party: Sponsor
First posted: Apr 21, 2008
Start date: Dec 2008
Primary completion: Oct 2014
Completion: Oct 30, 2017
Last update: Apr 28, 2020

Study contacts

Canales Miguel, Dr

study chair · Hospital La Paz

Lopez-Guillermo Armando, Dr

study chair · Hospital Clinic of Barcelona

Tomas Jose Francisco, Dr

study chair · MD Anderson- Madrid

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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