MIR: Rituximab and Involved Field Radiotherapy in Early Stage Follicular Lymphoma

Sponsor

Klaus Herfarth, MD (Other)

Overall Status

Completed

CT.gov ID

NCT00509184

Collaborator

German Low Grade Lymphoma Study Group (Other), Roche Pharma AG (Industry)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

N/A

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 :

Mar 1, 2008

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Outcome Measures

Primary Outcome Measures

progression free survival [2 years]

Secondary Outcome Measures

Response to Rituximab [7 weeks]
Rate of CR [18 weeks]
Toxicity (CTC Vers. 3) [2 yrs]
Relapse rate, Relapse pattern, DSF [2 yrs]
Overall survival [2 yrs]
QoL [2 yrs]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Charité Campus Mitte	Berlin	Germany	10117
2	Charité Campus Benjamin-Franklin	Berlin	Germany	12200
3	Charité Campus Buch	Berlin	Germany
4	University of Cologne	Cologne	Germany	50924
5	University of Dresden	Dresden	Germany	01307
6	University of Essen	Essen	Germany	45122
7	University of Göttingen	Göttingen	Germany	37075
8	University of Hannover	Hannover	Germany	30625
9	University of Heidelberg	Heidelberg	Germany	69120
10	University of Kiel	Kiel	Germany	24116
11	University of Mainz	Mainz	Germany	55101
12	University of Heidelberg (Campus Mannheim)	Mannheim	Germany	68167
13	University of Marburg	Marburg	Germany	35033
14	LMU	Munich	Germany	81377
15	TU	Munich	Germany	81675
16	University of Münster	Münster	Germany	48129
17	University of Ulm	Ulm	Germany	89081