Clinical trial · Interventional
Bendamustine Plus Rituximab Versus CHOP Plus Rituximab
Prospective Randomised Multicenter Study for Therapy Optimization (First Line) of Advanced Progredient, Low Malignant Non-Hodgkin Lymphomas and Mantle Cell Lymphomas
NCT00991211CI-TRIAL-00080084completedPhase 3ClinicalTrials.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)
The study addresses the question if the first line therapy of low malignant and mantle cell lymphomas with bendamustine plus rituximab is comparable (non inferior) with CHOP plus rituximab with regard to progression free survival (PFS).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphomas | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Immunocytomas | — | UNRESOLVED | — |
| Lymphocytic Lymphomas | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Marginal Zone Lymphomas | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Non-Hodgkin Lymphomas | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
| Standard chemotherapy CHOP + Ritiximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bendamustine + Rituximab
- description
- Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w
- interventionNames
- Drug: Bendamustine
- type
- ACTIVE_COMPARATOR
- label
- CHOP + Rituximab
- description
- Cyclophosphamid 750 mg/m² d 1 + Doxorubicin 50 mg/m² d 1 + Vincristin 1,4 mg/m² max. 2 mg d 1 + Prednison 100 mg absolute p.o. d 1-5 + Rituximab 375 mg/m² d 1 q3w
- interventionNames
- Drug: Standard chemotherapy CHOP + Ritiximab
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histological verified CD20-positive B-Cell-Lymphomas of the following entities: * Follicular lymphoma grade 1 and 2 * Immunocytoma and lymphoplasmocytic lymphoma * Marginal zone lymphoma, nodal and generalised * Mantle cell lymphoma * lymphocytic lymphoma (CLL without leucaemic characteristics) * non-specified/classified lymphomas of low malignancy * No prior therapy with cytotoxics,interferon or monoclonal antibodies * Need for therapy, except mantle cell lymphomas * Stadium III or IV * Written informed consent * Performance status WHO 0-2 * Histology not older than 6 months Exclusion Criteria: * Patients not establishing all above mentioned prerequisites * Option of a primary, potential curative radiation therapy * Pretreatment except a unique local delimited radiation (radiation fiel not expanding two adjacent lymph node regions * Comorbidities excluding a study conform therapy: * heart attack during the last 6 months * severe, medicinal not adjustable hypertonia * severe functional defects of the heart (NYHA III or IV) * lung (WHO grade III or IV), liver or kidney (creatinine \> 2 mg/dl, GOT + GPT or bilirubin 3 x ULN, except caused by lymphoma.
References
Publications (5)
- BACKGROUNDRummel MJ et al. Bendamustine Plus Rituximab Is Superior in Respect of Progression Free Survival and CR Rate When Compared to CHOP Plus Rituximab as First-Line Treatment of Patients with Advanced Follicular, Indolent, and Mantle Cell Lymphomas: Final Results of a Randomized Phase III Study of the StiL (Study Group Indolent Lymphomas, Germany). Blood 2009; 114: 405 https://doi.org/10.1182/blood.V114.22.405.405
- BACKGROUNDRummel MJ et al. Bendamustine plus rituximab (B-R) versus CHOP plus rituximab (CHOP-R) as first-line treatment in patients with indolent and mantle cell lymphomas (MCL): Updated results from the StiL NHL 1 study. DOI: 10.1200/jco.2012.30.15_suppl.3 Journal of Clinical Oncology 30, no. 15_suppl (May 2012) 3-3.
- BACKGROUNDRummel MJ et al. Subanalysis of the StiL NHL 1-2003 Study: Achievement of Complete Response with Bendamustine-Rituximab (B-R) and CHOP-R in the First-Line Treatment of Indolent and Mantle Cell Lymphomas Results in Superior Survival Compared to Partial Response. Blood 2012; 120: 2724.
- DERIVEDZohren F, Bruns I, Pechtel S, Schroeder T, Fenk R, Czibere A, Maschmeyer G, Kofahl-Krause D, Niederle N, Heil G, Losem C, Welslau M, Brugger W, Germing U, Kronenwett R, Barth J, Rummel MJ, Haas R, Kobbe G. Prognostic value of circulating Bcl-2/IgH levels in patients with follicular lymphoma receiving first-line immunochemotherapy. Blood. 2015 Sep 17;126(12):1407-14. doi: 10.1182/blood-2015-03-630012. Epub 2015 Aug 3. PMID 26239087
- DERIVEDRummel MJ, Niederle N, Maschmeyer G, Banat GA, von Grunhagen U, Losem C, Kofahl-Krause D, Heil G, Welslau M, Balser C, Kaiser U, Weidmann E, Durk H, Ballo H, Stauch M, Roller F, Barth J, Hoelzer D, Hinke A, Brugger W; Study group indolent Lymphomas (StiL). Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial. Lancet. 2013 Apr 6;381(9873):1203-10. doi: 10.1016/S0140-6736(12)61763-2. Epub 2013 Feb 20. PMID 23433739