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Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

Primary Purpose

Non-Hodgkin Lymphomas, Follicular Lymphomas, Immunocytomas

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Bendamustine
Standard chemotherapy CHOP + Ritiximab
Sponsored by
University of Giessen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin Lymphomas focused on measuring Comparison, Bendamustine + Rituximab, CHOP + Rituximab, Progression free survival, Overall survival, Toxicity, Safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • StiL Head Office; Justus-Liebig-University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bendamustine + Rituximab

CHOP + Rituximab

Arm Description

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

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

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

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

Full Information

First Posted
October 6, 2009
Last Updated
March 13, 2012
Sponsor
University of Giessen
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1. Study Identification

Unique Protocol Identification Number
NCT00991211
Brief Title
Bendamustine Plus Rituximab Versus CHOP Plus Rituximab
Official Title
Prospective Randomised Multicenter Study for Therapy Optimization (First Line) of Advanced Progredient, Low Malignant Non-Hodgkin Lymphomas and Mantle Cell Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Giessen

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphomas, Follicular Lymphomas, Immunocytomas, Lymphocytic Lymphomas, Marginal Zone Lymphomas
Keywords
Comparison, Bendamustine + Rituximab, CHOP + Rituximab, Progression free survival, Overall survival, Toxicity, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
549 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bendamustine + Rituximab
Arm Type
Experimental
Arm Description
Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w
Arm Title
CHOP + Rituximab
Arm Type
Active Comparator
Arm 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 Type
Drug
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Ribomustin, Treanda
Intervention Description
Comparison of Bendamustine + Rituximab with CHOP + Rituximab
Intervention Type
Drug
Intervention Name(s)
Standard chemotherapy CHOP + Ritiximab
Other Intervention Name(s)
Endoxan(R), Cyclostin(R) = Cyclophosphamide, Adriamycin(R) Doxorubicin, Oncovin(R) Vincristine, Prednison, Rituxan(R), MabThera(R) = Rituximab
Intervention 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
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
observation 3 years or significant differences between two arms
Secondary Outcome Measure Information:
Title
Determination and comparison of remission rates, of toxicity, infectious complications, overall survival, EFS, TTNT, capacity of peripheral blood stem cell mobilization
Time Frame
ongoing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathias Rummel, Dr.
Organizational Affiliation
Study Group of indolent Lymphom,as (StiL)
Official's Role
Principal Investigator
Facility Information:
Facility Name
StiL Head Office; Justus-Liebig-University
City
Giessen
ZIP/Postal Code
35392
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26239087
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.
Results Reference
derived
PubMed Identifier
23433739
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. Erratum In: Lancet. 2013 Apr 6;381(9873):1184.
Results Reference
derived

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Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

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