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

Study Overview
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Brief Summary
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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
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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

Official Title
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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®)

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: Rituximab
* Drug: Ibritumomab tiuxetan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg | Drug: Ibritumomab tiuxetan<br>* One dose of 90Y Ibritumomab tiuxetan, 0,4 mCi/Kg<br>|
| Active Comparator: B<br>Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months | Drug: Rituximab<br>* 375 mg/m2 every 8 weeks during 24 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Folicular Lymphoma, Consolidation, Maintenance