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NCT00991211 · CITED IN SOURCE DOCUMENTS

Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2024-08-22

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w
    intervention Names
    1. Drug: Bendamustine
    label
    Bendamustine + Rituximab
    type
    EXPERIMENTAL
  2. 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
    intervention Names
    1. Drug: Standard chemotherapy CHOP + Ritiximab
    label
    CHOP + Rituximab
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Bendamustine + Rituximab
    description
    Comparison of Bendamustine + Rituximab with CHOP + Rituximab
    name
    Bendamustine
    other Names
    1. Ribomustin, Treanda
    type
    DRUG
  2. arm Group Labels
    1. 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 as standard Chemotherapy
    name
    Standard chemotherapy CHOP + Ritiximab
    other Names
    1. Endoxan(R), Cyclostin(R) = Cyclophosphamide
    2. Adriamycin(R) Doxorubicin
    3. Oncovin(R) Vincristine
    4. Prednison
    5. Rituxan(R), MabThera(R) = Rituximab
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
549
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Progression free survival
    time Frame
    observation 3 years or significant differences between two arms
secondary Outcomes
  1. measure
    Determination and comparison of remission rates, of toxicity, infectious complications, overall survival, EFS, TTNT, capacity of peripheral blood stem cell mobilization
    time Frame
    ongoing
Full study description
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.
Source references
references
  1. citation
    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
    type
    BACKGROUND
  2. citation
    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.
    type
    BACKGROUND
  3. citation
    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.
    type
    BACKGROUND
  4. citation
    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
    type
    DERIVED
  5. citation
    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
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      1. context
        Updated: May 14, 2025
        datetime
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        display
        May 14, 2025

    Preserved source evidence · Independent clinical review pending · Not medical advice