Rituximab and Involved Field Radiotherapy in Early Stage Follicular Lymphoma

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00509184

Acronym

MIR

Enrollment

Registered

2007-07-31

Start date

2008-03-31

Completion date

2013-04-30

Last updated

2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Malignant

Keywords

untreated

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.

Interventions

DRUGRituximab

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
progression free survival	2 years

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026