Lymphoma, Malignant Clinical Trial
— MIROfficial title:
Therapy of Nodal Follicular Lymphoma (Grade I/II) Clinical Stage I or II Using Involved Field Radiotherapy in Combination With Rituximab
| Verified date | January 2020 |
| Source | Heidelberg University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 85 |
| Est. completion date | April 2013 |
| Est. primary completion date | April 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Charité Campus Benjamin-Franklin | Berlin | |
| Germany | Charité Campus Buch | Berlin | |
| Germany | Charité Campus Mitte | 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 | Hannover | |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Klaus Herfarth, MD | German Low Grade Lymphoma Study Group, Roche Pharma AG |
Germany,
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, Dörken B, Dürig J, Wiegel T, Hiddemann W, Hoster E, Pott C, Dreyling M. Rituximab With Involve — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | progression free survival | 2 years | ||
| Secondary | Response to Rituximab | 7 weeks | ||
| Secondary | Rate of CR | 18 weeks | ||
| Secondary | Toxicity (CTC Vers. 3) | 2 yrs | ||
| Secondary | Relapse rate, Relapse pattern, DSF | 2 yrs | ||
| Secondary | Overall survival | 2 yrs | ||
| Secondary | QoL | 2 yrs |
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