Rituximab and Involved Field Radiotherapy in Early Stage Follicular Lymphoma

Phase 2

Completed

• Conditions: Lymphoma, Malignant

• Registration Number: NCT00509184
• Lead Sponsor: Klaus Herfarth, MD

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2007-07-30
• Study First Submitted QC: 2007-07-30
• Study First Posted: 2007-07-31
• Study Start: 2008-03
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-02
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
progression free survival	2 years

Secondary Outcome Measures

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

Trial Locations

Locations (17)

University of Cologne; 🇩🇪 Cologne, Germany

University of Dresden; 🇩🇪 Dresden, Germany

University of Kiel; 🇩🇪 Kiel, Germany

University of Marburg; 🇩🇪 Marburg, Germany

University of Mainz; 🇩🇪 Mainz, Germany

LMU; 🇩🇪 Munich, Germany

University of Hannover; 🇩🇪 Hannover, Germany

University of Heidelberg (Campus Mannheim); 🇩🇪 Mannheim, Germany

TU; 🇩🇪 Munich, Germany

University of Münster; 🇩🇪 Münster, Germany

Charité Campus Benjamin-Franklin; 🇩🇪 Berlin, Germany

Charité Campus Mitte; 🇩🇪 Berlin, Germany

Charité Campus Buch; 🇩🇪 Berlin, Germany

University of Heidelberg; 🇩🇪 Heidelberg, Germany

University of Göttingen; 🇩🇪 Göttingen, Germany

University of Essen; 🇩🇪 Essen, Germany

University of Ulm; 🇩🇪 Ulm, Germany