Clinical trial · Interventional
Rituximab and Involved Field Radiotherapy in Early Stage Follicular Lymphoma
Therapy of Nodal Follicular Lymphoma (Grade I/II) Clinical Stage I or II Using Involved Field Radiotherapy in Combination With Rituximab
NCT00509184CI-TRIAL-00042599MIRcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Malignant | Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- progression free survival
- timeFrame
- 2 years
Secondary outcomes (6)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDWitzens-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. PMID 21352561
- RESULTHerfarth 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. PMID 31723798