Therapy of Nodal Follicular Lymphoma (Grade I/II) Clinical Stage I or II Using Involved Field Radiotherapy in Combination With Rituximab
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 85
- Locations
- 33
- Primary Endpoint
- progression free survival
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
progression free survival
Time Frame: 2 years
Secondary Outcomes
- 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)
Investigators
Klaus Herfarth, MD
Prof. Dr. K. Herfarth
Heidelberg University