Rituximab and Involved Field Radiotherapy in Early Stage Follicular Lymphoma
NCT ID: NCT00509184
Last Updated: 2020-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
85 participants
INTERVENTIONAL
2008-03-31
2013-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Rituximab
375 mg/m\^2, weekly (4 weeks), repeated after 4 weeks gap
Eligibility Criteria
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Inclusion Criteria
* only nodal involvement (incl. Waldeyer) clinical stage I or II
* largest tumor ≤ 7 cm
* adequate bone marrow reserves
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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German Low Grade Lymphoma Study Group
OTHER
Roche Pharma AG
INDUSTRY
Klaus Herfarth, MD
OTHER
Responsible Party
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Klaus Herfarth, MD
Prof. Dr. K. Herfarth
Principal Investigators
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Klaus Herfarth, MD
Role: PRINCIPAL_INVESTIGATOR
Heidelberg University
Locations
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Charité Campus Mitte
Berlin, , Germany
Charité Campus Benjamin-Franklin
Berlin, , Germany
Charité Campus Buch
Berlin, , Germany
University of Cologne
Cologne, , Germany
University of Dresden
Dresden, , Germany
University of Essen
Essen, , Germany
University of Göttingen
Göttingen, , Germany
University of Hannover
Hanover, , Germany
University of Heidelberg
Heidelberg, , Germany
University of Kiel
Kiel, , Germany
University of Mainz
Mainz, , Germany
University of Heidelberg (Campus Mannheim)
Mannheim, , Germany
University of Marburg
Marburg, , Germany
LMU
Munich, , Germany
TU
Munich, , Germany
University of Münster
Münster, , Germany
University of Ulm
Ulm, , Germany
Countries
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References
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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.
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.
Related Links
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German low grade lymphoma study group
German network for malignant lymphomas
Other Identifiers
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MIR 2006-001212-72
Identifier Type: -
Identifier Source: org_study_id
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