Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

NCT00991211 | Completed Phase 3 DMC

• 1 other identifier: NHL 1-2003
• Study Type: interventional
• Target: 549
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Comparison; Bendamustine + Rituximab; CHOP + Rituximab; Progression free survival; Overall survival; Toxicity; Safety

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  observation 3 years or significant differences between two arms

Secondary Outcomes (1)

• Determination and comparison of remission rates, of toxicity, infectious complications, overall survival, EFS, TTNT, capacity of peripheral blood stem cell mobilization

  ongoing

Study Arms (2)

Bendamustine + Rituximab

EXPERIMENTAL

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

Drug: Bendamustine

CHOP + Rituximab

ACTIVE COMPARATOR

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

Drug: Standard chemotherapy CHOP + Ritiximab

Interventions

Bendamustine DRUG

Comparison of Bendamustine + Rituximab with CHOP + Rituximab

Also known as: Ribomustin, Treanda

Bendamustine + Rituximab

Standard chemotherapy CHOP + Ritiximab 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

Also known as: Endoxan(R), Cyclostin(R) = Cyclophosphamide, Adriamycin(R) Doxorubicin, Oncovin(R) Vincristine, Prednison, Rituxan(R), MabThera(R) = Rituximab

CHOP + Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

StiL Head Office; Justus-Liebig-University

Giessen, 35392, Germany

Location

Related Publications (5)

• 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

  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.

  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.

  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.

  PMID: 26239087 DERIVED

• 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.

  PMID: 23433739 DERIVED

MeSH Terms

Conditions

Lymphoma, Follicular; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Bendamustine Hydrochloride; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mathias Rummel, Dr.

  Study Group of indolent Lymphom,as (StiL)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Group indolent Lymphomas (StiL)

Study Record Dates

• First Submitted: October 6, 2009
• First Posted: October 7, 2009
• Study Start: January 1, 2004
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

DE (1)