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

This study has been completed.
Sponsor:
Collaborators:
German Low Grade Lymphoma Study Group
Roche Pharma AG
Information provided by (Responsible Party):
Klaus Herfarth - Dr. J. Debus, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00509184
First received: July 30, 2007
Last updated: July 21, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Lymphoma, Malignant
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response to Rituximab [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Rate of CR [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Toxicity (CTC Vers. 3) [ Time Frame: 2 yrs ] [ Designated as safety issue: Yes ]
  • Relapse rate, Relapse pattern, DSF [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]
  • QoL [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]

Enrollment: 85
Study Start Date: March 2008
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rituximab
    375 mg/m^2, weekly (4 weeks), repeated after 4 weeks gap
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509184

Locations
Germany
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
LMU
Munich, Germany, 81377
TU
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
Investigators
Principal Investigator: Klaus Herfarth, MD Heidelberg University
  More Information

Additional Information:
Publications:
Responsible Party: Klaus Herfarth - Dr. J. Debus, Prof. Dr. K. Herfarth, University of Heidelberg
ClinicalTrials.gov Identifier: NCT00509184     History of Changes
Other Study ID Numbers: MIR 2006-001212-72
Study First Received: July 30, 2007
Last Updated: July 21, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Heidelberg University:
untreated

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

ClinicalTrials.gov processed this record on September 18, 2014