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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Lymphoma, Malignant

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression free survival

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Klaus Herfarth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Heidelberg

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

MIR 2006-001212-72

NCT ID:

NCT00509184

Start Date:

March 2008

Completion Date:

December 2012

Related Keywords:

  • Lymphoma, Malignant
  • untreated
  • Lymphoma
  • Lymphoma, Follicular

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