Rituximab and Involved Field Radiotherapy in Early Stage Follicular Lymphoma

Klaus Herfarth, MD85 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma, Malignant

Interventions

RituximabDRUG

375 mg/m\^2, weekly (4 weeks), repeated after 4 weeks gap

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (17)

Charité Campus Mitte

Berlin, Germany

Charité Campus Benjamin-Franklin

Berlin, Germany

Charité Campus Buch

Berlin, Germany

Outcomes

Primary Outcomes

progression free survival

Time frame: 2 years

Secondary Outcomes

Response to Rituximab

Time frame: 7 weeks

Rate of CR

Time frame: 18 weeks

Toxicity (CTC Vers. 3)

Time frame: 2 yrs

Relapse rate, Relapse pattern, DSF

Time frame: 2 yrs

Overall survival

Time frame: 2 yrs

QoL

Time frame: 2 yrs

Data from ClinicalTrials.gov

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