Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

NCT ID: NCT00991211

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 549 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2009-08-31

Brief Summary

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).

Detailed Description

The 4 agent chemotherapy (CTX) CHOP (cyclophosphamide, doxorubicin, vincristine prednisone) in combination with the monoclonal anti-CD20 antibody rituximab (CHOP-R) represents a standard CTX for the treatment of lymphomas of high or low malignancy. The combination of bendamustine and rituximab (B-R) is also highly effective with a more advantageous toxicity profile. If B-R could be shown to be non inferior to CHOP-R, this could improve the quality of life of the patient and possibly also the prognosis.

Conditions

Non-Hodgkin Lymphomas; Follicular Lymphomas; Immunocytomas; Lymphocytic Lymphomas; Marginal Zone Lymphomas

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bendamustine + Rituximab

Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w

Group Type: EXPERIMENTAL

Bendamustine

Intervention Type: DRUG

Comparison of Bendamustine + Rituximab with CHOP + Rituximab

CHOP + Rituximab

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

Group Type: ACTIVE_COMPARATOR

Standard chemotherapy CHOP + Ritiximab

Intervention Type: DRUG

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 as standard Chemotherapy

Interventions

Bendamustine

Comparison of Bendamustine + Rituximab with CHOP + Rituximab

Intervention Type: DRUG

Standard chemotherapy CHOP + Ritiximab

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 as standard Chemotherapy

Intervention Type: DRUG

Other Intervention Names

Ribomustin, Treanda; Endoxan(R), Cyclostin(R) = Cyclophosphamide; Adriamycin(R) Doxorubicin; Oncovin(R) Vincristine; Prednison; Rituxan(R), MabThera(R) = Rituximab

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Giessen

OTHER

Sponsor Role: lead

Responsible Party

Jurgen Barth

Study Group indolent Lymphomas (StiL)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mathias Rummel, Dr.

Role: PRINCIPAL_INVESTIGATOR

Study Group of indolent Lymphom,as (StiL)

Locations

StiL Head Office; Justus-Liebig-University

Giessen, , Germany

Countries

Germany

References

Rummel 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

Reference Type: BACKGROUND

Rummel 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.

Reference Type: BACKGROUND

Rummel 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.

Reference Type: BACKGROUND

Zohren 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.

Reference Type: DERIVED

PMID: 26239087 (View on PubMed)

Rummel 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.

Reference Type: DERIVED

PMID: 23433739 (View on PubMed)

Other Identifiers

NHL 1-2003

Identifier Type: -

Identifier Source: org_study_id