NCT00662948

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®)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	375 mg/m2 every 8 weeks during 24 months
DRUG	Ibritumomab tiuxetan	One dose of 90Y Ibritumomab tiuxetan, 0,4 mCi/Kg

Timeline

• Start date: 2008-12-01
• Primary completion: 2014-10-01
• Completion: 2017-10-30
• First posted: 2008-04-21
• Last updated: 2020-04-28

Locations

21 sites across 1 country: Spain