Rituximab and Involved Field Radiotherapy in Early Stage Follicular Lymphoma (MIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00509184
Recruitment Status : Completed
First Posted : July 31, 2007
Last Update Posted : July 23, 2013
German Low Grade Lymphoma Study Group
Roche Pharma AG
Information provided by (Responsible Party):
Klaus Herfarth - Dr. J. Debus, Heidelberg University

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.

Condition or disease Intervention/treatment Phase
Lymphoma, Malignant Drug: Rituximab Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapy of Nodal Follicular Lymphoma (Grade I/II) Clinical Stage I or II Using Involved Field Radiotherapy in Combination With Rituximab
Study Start Date : March 2008
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Intervention Details:
  • Drug: Rituximab
    375 mg/m^2, weekly (4 weeks), repeated after 4 weeks gap

Primary Outcome Measures :
  1. progression free survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Response to Rituximab [ Time Frame: 7 weeks ]
  2. Rate of CR [ Time Frame: 18 weeks ]
  3. Toxicity (CTC Vers. 3) [ Time Frame: 2 yrs ]
  4. Relapse rate, Relapse pattern, DSF [ Time Frame: 2 yrs ]
  5. Overall survival [ Time Frame: 2 yrs ]
  6. QoL [ Time Frame: 2 yrs ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00509184

Charité Campus Mitte
Berlin, Germany, 10117
Charité Campus Benjamin-Franklin
Berlin, Germany, 12200
Charité Campus Buch
Berlin, Germany
University of Cologne
Cologne, Germany, 50924
University of Dresden
Dresden, Germany, 01307
University of Essen
Essen, Germany, 45122
University of Göttingen
Göttingen, Germany, 37075
University of Hannover
Hannover, Germany, 30625
University of Heidelberg
Heidelberg, Germany, 69120
University of Kiel
Kiel, Germany, 24116
University of Mainz
Mainz, Germany, 55101
University of Heidelberg (Campus Mannheim)
Mannheim, Germany, 68167
University of Marburg
Marburg, Germany, 35033
Munich, Germany, 81377
Munich, Germany, 81675
University of Münster
Münster, Germany, 48129
University of Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
Klaus Herfarth - Dr. J. Debus
German Low Grade Lymphoma Study Group
Roche Pharma AG
Principal Investigator: Klaus Herfarth, MD Heidelberg University

Additional Information:
Responsible Party: Klaus Herfarth - Dr. J. Debus, Prof. Dr. K. Herfarth, Heidelberg University Identifier: NCT00509184     History of Changes
Other Study ID Numbers: MIR 2006-001212-72
First Posted: July 31, 2007    Key Record Dates
Last Update Posted: July 23, 2013
Last Verified: July 2013

Keywords provided by Klaus Herfarth - Dr. J. Debus, Heidelberg University:

Additional relevant MeSH terms:
Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents