Clinical trial NCT00509184: Rituximab and Involved Field Radiotherapy in Early Stage Follicular Lymphoma
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Malignant
Keywords: untreated
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: German Low Grade Lymphoma Study Group
name: Roche Pharma AG
First posted: 2007-07-31
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: progression free survival
timeFrame: 2 years
Secondary outcomes:
measure: Response to Rituximab
timeFrame: 7 weeks
measure: Rate of CR
timeFrame: 18 weeks
measure: Toxicity (CTC Vers. 3)
timeFrame: 2 yrs
measure: Relapse rate, Relapse pattern, DSF
timeFrame: 2 yrs
measure: Overall survival
timeFrame: 2 yrs
measure: QoL
timeFrame: 2 yrs
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Campus Mitte
city: Berlin
country: Germany
facility: Charité Campus Benjamin-Franklin
city: Berlin
country: Germany
facility: Charité Campus Buch
city: Cologne
country: Germany
facility: University of Cologne
city: Dresden
country: Germany
facility: University of Dresden
city: Essen
country: Germany
facility: University of Essen
city: Göttingen
country: Germany
facility: University of Göttingen
city: Hannover
country: Germany
facility: University of Hannover
city: Heidelberg
country: Germany
facility: University of Heidelberg
city: Kiel
country: Germany
facility: University of Kiel
city: Mainz
country: Germany
facility: University of Mainz
city: Mannheim
country: Germany
facility: University of Heidelberg (Campus Mannheim)
city: Marburg
country: Germany
facility: University of Marburg
city: Munich
country: Germany
facility: LMU
city: Munich
country: Germany
facility: TU
city: Münster
country: Germany
facility: University of Münster
city: Ulm
country: Germany
facility: University of Ulm
Study officials:
affiliation: Heidelberg University
name: Klaus Herfarth, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.