search
Back to results

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

Primary Purpose

Lymphoma, Malignant

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Rituximab
Sponsored by
Klaus Herfarth, MD
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Malignant focused on measuring untreated

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Charité Campus Mitte
  • Charité Campus Benjamin-Franklin
  • Charité Campus Buch
  • University of Cologne
  • University of Dresden
  • University of Essen
  • University of Göttingen
  • University of Hannover
  • University of Heidelberg
  • University of Kiel
  • University of Mainz
  • University of Heidelberg (Campus Mannheim)
  • University of Marburg
  • LMU
  • TU
  • University of Münster
  • University of Ulm

Outcomes

Primary Outcome Measures

progression free survival

Secondary Outcome Measures

Response to Rituximab
Rate of CR
Toxicity (CTC Vers. 3)
Relapse rate, Relapse pattern, DSF
Overall survival
QoL

Full Information

First Posted
July 30, 2007
Last Updated
January 2, 2020
Sponsor
Klaus Herfarth, MD
Collaborators
German Low Grade Lymphoma Study Group, Roche Pharma AG
search

1. Study Identification

Unique Protocol Identification Number
NCT00509184
Brief Title
Rituximab and Involved Field Radiotherapy in Early Stage Follicular Lymphoma
Acronym
MIR
Official Title
Therapy of Nodal Follicular Lymphoma (Grade I/II) Clinical Stage I or II Using Involved Field Radiotherapy in Combination With Rituximab
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Klaus Herfarth, MD
Collaborators
German Low Grade Lymphoma Study Group, Roche Pharma AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Malignant
Keywords
untreated

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
375 mg/m^2, weekly (4 weeks), repeated after 4 weeks gap
Primary Outcome Measure Information:
Title
progression free survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Response to Rituximab
Time Frame
7 weeks
Title
Rate of CR
Time Frame
18 weeks
Title
Toxicity (CTC Vers. 3)
Time Frame
2 yrs
Title
Relapse rate, Relapse pattern, DSF
Time Frame
2 yrs
Title
Overall survival
Time Frame
2 yrs
Title
QoL
Time Frame
2 yrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Herfarth, MD
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charité Campus Benjamin-Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Charité Campus Buch
City
Berlin
Country
Germany
Facility Name
University of Cologne
City
Cologne
ZIP/Postal Code
50924
Country
Germany
Facility Name
University of Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
University of Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
University of Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
University of Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
University of Kiel
City
Kiel
ZIP/Postal Code
24116
Country
Germany
Facility Name
University of Mainz
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
University of Heidelberg (Campus Mannheim)
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
University of Marburg
City
Marburg
ZIP/Postal Code
35033
Country
Germany
Facility Name
LMU
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
TU
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
University of Münster
City
Münster
ZIP/Postal Code
48129
Country
Germany
Facility Name
University of Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21352561
Citation
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 Feb 26;11:87. doi: 10.1186/1471-2407-11-87.
Results Reference
background
PubMed Identifier
31723798
Citation
Herfarth K, Borchmann P, Schnaidt S, Hohloch K, Budach V, Engelhard M, Viardot A, Engenhart-Cabillic R, Keller U, Reinartz G, Eich HT, Witzens-Harig M, Hess CF, Dorken B, Durig J, Wiegel T, Hiddemann W, Hoster E, Pott C, Dreyling M. Rituximab With Involved Field Irradiation for Early-stage Nodal Follicular Lymphoma: Results of the MIR Study. Hemasphere. 2018 Nov 30;2(6):e160. doi: 10.1097/HS9.0000000000000160. eCollection 2018 Dec.
Results Reference
result
Links:
URL
http://www.glsg.de
Description
German low grade lymphoma study group
URL
http://www.lymphome.de
Description
German network for malignant lymphomas

Learn more about this trial

Rituximab and Involved Field Radiotherapy in Early Stage Follicular Lymphoma

We'll reach out to this number within 24 hrs