Rituximab and Involved Field Radiotherapy in Early Stage Follicular Lymphoma

Study Overview
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Brief Summary
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Combination of involved field radiotherapy for the control of macroscopic disease and CD20 antibody Rituximab for the control of microscopic remainders in other regions in patients with early stage nodal follicular lymphoma /grade I or II). Evaluation of DFSl and toxicity.

Detailed Description
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The MIR (Mabthera(R) and Involved field Radiation) study is a prospective multicenter trial combining systemic treatment with the anti CD20 antibody Rituximab (Mabthera(R)) in combination with involved field radiotherapy (30 - 40 Gy). This trial aims at testing the combination's efficacy and safety with an accrual of 85 patients.Primary endpoint of the study is progression free survival. Secondary endpoints are response rate to Rituximab, complete remission rate at week 18, relapse rate, relapse pattern, relapse free survival, overall survival, toxicity and quality of life. More details: Witzens-Harig M, Hensel M, Unterhalt M, Herfarth K. Treatment of limited stage follicular lymphoma with Rituximab immunotherapy and involved field radiotherapy in a prospective multicenter Phase II trial-MIR trial. BMC cancer. 2011; 11: 87.

Official Title
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Therapy of Nodal Follicular Lymphoma (Grade I/II) Clinical Stage I or II Using Involved Field Radiotherapy in Combination With Rituximab

Conditions
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Lymphoma, Malignant

Intervention / Treatment
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* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: verified follicular lymphoma grade 1 or 2 only nodal involvement (incl. Waldeyer) clinical stage I or II largest tumor ≤ 7 cm adequate bone marrow reserves Exclusion Criteria: ECOG >2 Follicular lymphoma grade 3 buky disease (>7 cm) involvement of the spleen neoplasia in PMH (except: basalioma, spinalioma) Immunodeficiency syndromes, viral hepatitis, connective tissue disease severe psychiatric disease pregnancy or breast feeding known allergies against foreign proteins

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rituximab|375 mg/m^2, weekly (4 weeks), repeated after 4 weeks gap|

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 |
| --- | --- | --- |
| Response to Rituximab |  | 7 weeks | 
| Rate of CR |  | 18 weeks | 
| Toxicity (CTC Vers. 3) |  | 2 yrs | 
| Relapse rate, Relapse pattern, DSF |  | 2 yrs | 
| Overall survival |  | 2 yrs | 
| QoL |  | 2 yrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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untreated